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A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02004093
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: pertuzumab
Drug: paclitaxel
Drug: gemcitabine
Drug: carboplatin
Enrollment 149
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Period Title: Overall Study
Started 75 [1] 74
Completed 1 1
Not Completed 74 73
Reason Not Completed
Death             2             1
Lack of Efficacy             66             62
Protocol Violation             0             1
Lost to Follow-up             0             1
Withdrawal by Subject             3             7
Not specified             3             1
[1]
Includes 1 participant who was randomized to chemotherapy group but received pertuzumab+chemotherapy
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy Total
Hide Arm/Group Description

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off. Total of all reporting groups
Overall Number of Baseline Participants 74 75 149
Hide Baseline Analysis Population Description
All participants who received randomized treatment (All Treated Population, for Efficacy Analyses); 1 participant was randomized to the chemotherapy arm but received pertuzumab+chemotherapy and is thus included in this arm for all analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 75 participants 149 participants
58.1  (10.16) 55.3  (11.41) 56.7  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 75 participants 149 participants
Female
74
 100.0%
75
 100.0%
149
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Disease Progression or Death
Hide Description Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Measure Type: Number
Unit of Measure: percentage of participants
87.8 80.0
2.Primary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Median (Full Range)
Unit of Measure: weeks
34.1
(31 to 38)
40.0
(33 to 43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3967
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4552
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3972
Comments p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.17
Confidence Interval (2-Sided) 80%
0.92 to 1.49
Estimation Comments [Not Specified]
3.Primary Outcome
Title Kaplan-Meier Probability of No Disease or Progression at 1 Year
Hide Description The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Measure Type: Number
Unit of Measure: percent
24 21
4.Secondary Outcome
Title Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Hide Description Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were “response”, “stable disease” and “progressive disease”. Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of “response” or “progressive disease”.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Measure Type: Number
Unit of Measure: percentage of participants
74.3 68.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3943
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 6.32
Confidence Interval (2-Sided) 80%
-3.9 to 16.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 80%
0.86 to 2.17
Estimation Comments approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method
5.Secondary Outcome
Title Duration of Response
Hide Description For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
Time Frame Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:
Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 47 38
Median (Inter-Quartile Range)
Unit of Measure: weeks
28.7
(22 to 48)
37.0
(25 to 43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3655
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1319
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3679
Comments [Not Specified]
Method Wald test
Comments p-value resulting from Wald test of null hypothesis that the hazard ratio=1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.22
Confidence Interval (2-Sided) 80%
0.92 to 1.61
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 55 51
Measure Type: Number
Unit of Measure: percent
18 18
7.Secondary Outcome
Title Percentage of Participants With Disease Progression
Hide Description Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in analysis
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Measure Type: Number
Unit of Measure: percentage of participants
83.8 76.0
8.Secondary Outcome
Title Time to Progressive Disease
Hide Description The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients with an event (disease progression) were included in analysis
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 62 57
Median (Inter-Quartile Range)
Unit of Measure: weeks
34.3
(27 to 48)
37.3
(29 to 47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8129
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6920
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8137
Comments [Not Specified]
Method Wald test
Comments p-value resulting from Wald test of null hypothesis that the hazard ratio=1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 80%
0.82 to 1.32
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Kaplan-Meier Probability of Being Progression Free at 1 Year
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: percent
24 19
10.Secondary Outcome
Title Time To Response
Hide Description Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with a response were included in the analysis.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: weeks
6.0
(5 to 17)
6.3
(5 to 15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5726
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3903
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5870
Comments [Not Specified]
Method Wald test
Comments p-value resulting from Wald test of null hypothesis that the hazard ratio=1
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 80%
0.87 to 1.43
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description [Not Specified]
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in analysis
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Measure Type: Number
Unit of Measure: percentage of participants
45.9 41.3
12.Secondary Outcome
Title Overall Survival
Hide Description Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.
Time Frame Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants were included in analysis
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description:

Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 74 75
Median (Full Range)
Unit of Measure: months
28.2
(1 to 52)
NA [1] 
(1 to 34)
[1]
Given the duration of follow-up at time of data analysis the median had not been reached and could not be calculated (at least 50% of patients had not died).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9261
Comments [Not Specified]
Method Log Rank
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Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8591
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
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Statistical Analysis Overview Comparison Group Selection Chemotherapy + Pertuzumab, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9262
Comments p-value resulting from Wald test of null hypothesis that the hazard ratio=1
Method Wald test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 80%
0.74 to 1.41
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Kaplan-Meier Probability of Being Alive at 1 Year
Hide Description [Not Specified]
Time Frame 1 year
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Hide Analysis Population Description
All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
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Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.

Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Unit of Measure: percent
88 85
Time Frame Adverse events were collected from the date of randomization until 28 days after the last dose of the pertuzumab and/ or standard chemotherapy and continuously until end of study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy + Pertuzumab Chemotherapy
Hide Arm/Group Description Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles. Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
All-Cause Mortality
Chemotherapy + Pertuzumab Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy + Pertuzumab Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   20/75 (26.67%)   12/74 (16.22%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/75 (0.00%)  3/74 (4.05%) 
Anaemia  1  0/75 (0.00%)  1/74 (1.35%) 
Cardiac disorders     
Cardiac failure congestive  1  1/75 (1.33%)  0/74 (0.00%) 
Left ventricular dysfunction  1  1/75 (1.33%)  0/74 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/75 (2.67%)  1/74 (1.35%) 
Ascites  1  1/75 (1.33%)  1/74 (1.35%) 
Diarrhoea  1  2/75 (2.67%)  0/74 (0.00%) 
Intestinal obstruction  1  2/75 (2.67%)  0/74 (0.00%) 
Vomiting  1  2/75 (2.67%)  0/74 (0.00%) 
Constipation  1  0/75 (0.00%)  1/74 (1.35%) 
Gastrointestinal haemorrhage  1  1/75 (1.33%)  0/74 (0.00%) 
Ileus paralytic  1  1/75 (1.33%)  0/74 (0.00%) 
Large intesting perforation  1  0/75 (0.00%)  1/74 (1.35%) 
General disorders     
Pyrexia  1  2/75 (2.67%)  0/74 (0.00%) 
Local swelling  1  1/75 (1.33%)  0/74 (0.00%) 
Obstruction  1  0/75 (0.00%)  1/74 (1.35%) 
Hepatobiliary disorders     
Hepatic lesion  1  1/75 (1.33%)  0/74 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  4/75 (5.33%)  0/74 (0.00%) 
Infections and infestations     
Appendicitis  1  0/75 (0.00%)  1/74 (1.35%) 
Cystitis  1  1/75 (1.33%)  0/74 (0.00%) 
Lower respiratory tract infection  1  1/75 (1.33%)  0/74 (0.00%) 
Pneumonia  1  1/75 (1.33%)  0/74 (0.00%) 
Sinusitis  1  0/75 (0.00%)  1/74 (1.35%) 
Investigations     
Blood glucose increased  1  1/75 (1.33%)  0/74 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/75 (0.00%)  1/74 (1.35%) 
Nervous system disorders     
Neuropathy peripheral  1  1/75 (1.33%)  0/74 (0.00%) 
Syncope  1  1/75 (1.33%)  0/74 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/75 (1.33%)  1/74 (1.35%) 
Diaphragmatic hernia  1  1/75 (1.33%)  0/74 (0.00%) 
Epistaxis  1  1/75 (1.33%)  0/74 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy + Pertuzumab Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   72/75 (96.00%)   68/74 (91.89%) 
Blood and lymphatic system disorders     
Neutropenia  1  36/75 (48.00%)  43/74 (58.11%) 
Anaemia  1  19/75 (25.33%)  21/74 (28.38%) 
Thrombocytopenia  1  11/75 (14.67%)  18/74 (24.32%) 
Leukopenia  1  9/75 (12.00%)  12/74 (16.22%) 
Gastrointestinal disorders     
Nausea  1  44/75 (58.67%)  33/74 (44.59%) 
Diarrhoea  1  44/75 (58.67%)  14/74 (18.92%) 
Vomiting  1  24/75 (32.00%)  22/74 (29.73%) 
Constipation  1  20/75 (26.67%)  22/74 (29.73%) 
Abdominal pain  1  18/75 (24.00%)  14/74 (18.92%) 
Dyspepsia  1  9/75 (12.00%)  6/74 (8.11%) 
Stomatitis  1  10/75 (13.33%)  3/74 (4.05%) 
Abdominal pain upper  1  5/75 (6.67%)  2/74 (2.70%) 
Hemorrhoids  2  6/75 (8.00%)  1/74 (1.35%) 
Abdominal distension  1  1/75 (1.33%)  4/74 (5.41%) 
Abdominal pain lower  1  4/75 (5.33%)  0/74 (0.00%) 
General disorders     
Fatigue  1  30/75 (40.00%)  27/74 (36.49%) 
Asthenia  1  9/75 (12.00%)  10/74 (13.51%) 
Oedema peripheral  1  4/75 (5.33%)  6/74 (8.11%) 
Mucosal inflammation  1  7/75 (9.33%)  1/74 (1.35%) 
Pyrexia  1  5/75 (6.67%)  3/74 (4.05%) 
Chest pain  1  5/75 (6.67%)  1/74 (1.35%) 
Immune system disorders     
Drug hypersensitivity  1  11/75 (14.67%)  13/74 (17.57%) 
Infections and infestations     
Urinary tract infection  1  6/75 (8.00%)  2/74 (2.70%) 
Cystitis  1  7/75 (9.33%)  0/74 (0.00%) 
Nasopharyngitis  1  5/75 (6.67%)  2/74 (2.70%) 
Metabolism and nutrition disorders     
Decreased appetite  1  19/75 (25.33%)  4/74 (5.41%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  11/75 (14.67%)  4/74 (5.41%) 
Bone pain  1  5/75 (6.67%)  7/74 (9.46%) 
Myalgia  1  5/75 (6.67%)  6/74 (8.11%) 
Pain in extremity  1  6/75 (8.00%)  5/74 (6.76%) 
Back pain  1  6/75 (8.00%)  3/74 (4.05%) 
Muscle spasms  1  7/75 (9.33%)  1/74 (1.35%) 
Musculoskeletal pain  1  5/75 (6.67%)  2/74 (2.70%) 
Nervous system disorders     
Headache  1  16/75 (21.33%)  8/74 (10.81%) 
Dizziness  1  9/75 (12.00%)  6/74 (8.11%) 
Dysgeusia  1  10/75 (13.33%)  5/74 (6.76%) 
Neuropathy peripheral  1  11/75 (14.67%)  4/74 (5.41%) 
Peripheral sensory neuropathy  1  8/75 (10.67%)  4/74 (5.41%) 
Paraesthesia  1  4/75 (5.33%)  4/74 (5.41%) 
Lethargy  1  4/75 (5.33%)  2/74 (2.70%) 
Psychiatric disorders     
Insomnia  1  6/75 (8.00%)  5/74 (6.76%) 
Reproductive system and breast disorders     
Vaginal discharge  1  4/75 (5.33%)  0/74 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  14/75 (18.67%)  3/74 (4.05%) 
Dyspnoea  1  8/75 (10.67%)  5/74 (6.76%) 
Cough  1  5/75 (6.67%)  4/74 (5.41%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  22/75 (29.33%)  25/74 (33.78%) 
Rash  1  17/75 (22.67%)  7/74 (9.46%) 
Pruritus  1  7/75 (9.33%)  9/74 (12.16%) 
Nail disorder  1  8/75 (10.67%)  0/74 (0.00%) 
Erythema  1  5/75 (6.67%)  2/74 (2.70%) 
Dry skin  1  4/75 (5.33%)  1/74 (1.35%) 
Vascular disorders     
Phlebitis  1  3/75 (4.00%)  5/74 (6.76%) 
Flushing  1  5/75 (6.67%)  2/74 (2.70%) 
Hypertension  1  6/75 (8.00%)  0/74 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
2
Term from vocabulary, MedDRA13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02004093     History of Changes
Other Study ID Numbers: BO17931
First Submitted: December 3, 2013
First Posted: December 6, 2013
Results First Submitted: July 31, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014