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Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01280058
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : February 7, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Acinar Cell Carcinoma
Pancreatic Ductal Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer
Interventions Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Biological: Wild-type Reovirus
Enrollment 73
Recruitment Details Patients were randomized between February 2011 and April 2014
Pre-assignment Details  
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Period Title: Overall Study
Started 36 37
Completed 36 37
Not Completed 0 0
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel) Total
Hide Arm/Group Description

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 36 37 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants 37 participants 73 participants
61.5
(39 to 84)
66
(45 to 81)
64
(39 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
Female 14 18 32
Male 22 19 41
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
American Indian or Alaska Native 1 0 1
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 2 0 2
White 32 35 67
More than one race 0 1 1
Unknown or Not Reported 1 1 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants 37 participants 73 participants
36 37 73
1.Primary Outcome
Title Progression-free Survival Using RECIST v. 1.1
Hide Description The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.
Time Frame From study entry to the date of documented progression and/or death, assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Overall Number of Participants Analyzed 36 37
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(3.0 to 6.3)
5.2
(2.3 to 6.2)
2.Secondary Outcome
Title Incidence of Severe (Grade 3+) Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment, as Assessed by NCI CTCAE Version 4.0
Hide Description Toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher’s exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Overall Number of Participants Analyzed 36 37
Measure Type: Number
Unit of Measure: percentage of patients
Neutropenia 56 59
Leukopenia 33 46
Thrombocytopenia 28 24
Anemia 25 30
Febrile Neutropenia 8 11
Fatigue 11 8
Infection 11 5
Dose Delay 37 54
Dose reduction 36 43
3.Secondary Outcome
Title Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1
Hide Description 95% confidence intervals will be calculated. Differences in objective response rates between the treatment arms will be assessed using Fisher’s exact test.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Overall Number of Participants Analyzed 36 37
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response 7 7
Complete Response 0 0
4.Secondary Outcome
Title Overall Survival
Hide Description Evaluated and compared between the two treatment groups using log-rank statistics and graphically using the methods of Kaplan and Meier.
Time Frame From study entry to the time of death due to any cause, assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Overall Number of Participants Analyzed 36 37
Median (95% Confidence Interval)
Unit of Measure: months
7.3
(4.8 to 11.2)
8.8
(6.6 to 11.8)
5.Other Pre-specified Outcome
Title Immunologic Correlative Markers
Hide Description The inflammatory cytokine profile, immune effector cell phenotype and function, and NARA titers will be assessed and compared. Patterns of change in the longitudinal data on these markers will be evaluated for each of the correlative outcomes of interest.
Time Frame Up to day 1 of course 12
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected
Arm/Group Title Arm I (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm II (Carboplatin, Paclitaxel)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Percentage of Patients With Ras Pathway Activation
Hide Description The 95% confidence interval will be assessed. Cochran-Mantel-Haenszel test will be used to assess differences in the relationships between response and Ras pathway activation and the association of treatment groups on these relationships.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Wild-type Reovirus: Given IV

Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Overall Number of Participants Analyzed 36 37
Measure Type: Number
Unit of Measure: percentage of patients
71 75
Time Frame [Not Specified]
Adverse Event Reporting Description The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
 
Arm/Group Title Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Hide Arm/Group Description Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin and Paclitaxel were given IV. Wild-type Reovirus: Given IV Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Carboplatin and Paclitaxel were given IV
All-Cause Mortality
Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/36 (100.00%)      37/37 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  10/36 (27.78%)  10 11/37 (29.73%)  11
Febrile Neutropenia  1  4/36 (11.11%)  4 5/37 (13.51%)  5
Cardiac disorders     
Atrial fibrillation  1  2/36 (5.56%)  2 0/37 (0.00%)  0
Cardiac arrest  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Chest pain-cardiac  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Sinus tachycardia  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  2/36 (5.56%)  2 2/37 (5.41%)  2
Abdominal pain  1  6/36 (16.67%)  6 5/37 (13.51%)  5
Ascites  1  3/36 (8.33%)  3 3/37 (8.11%)  3
Constipation  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Diarrhea  1  2/36 (5.56%)  2 3/37 (8.11%)  3
Bloating  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Gastric hemorrhage  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Gastric ulcer  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Lower gastrointestional hemorrhage  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Nausea  1  7/36 (19.44%)  7 7/37 (18.92%)  7
Pancreatitis  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Rectal hemorrhage  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Vomiting  1  5/36 (13.89%)  5 4/37 (10.81%)  4
General disorders     
Edema limbs  1  2/36 (5.56%)  2 1/37 (2.70%)  1
Fatigue  1  6/36 (16.67%)  6 2/37 (5.41%)  2
Fever  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Infusion related reaction  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Pain  1  2/36 (5.56%)  2 3/37 (8.11%)  3
Non-cardiac chest pain  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Hepatobiliary disorders     
Bile duct stenosis  1  3/36 (8.33%)  3 0/37 (0.00%)  0
Infections and infestations     
Device related infection  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Infections  1  2/36 (5.56%)  2 2/37 (5.41%)  2
Lung Infection  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Sepsis  1  3/36 (8.33%)  3 1/37 (2.70%)  1
Skin Infection  1  2/36 (5.56%)  2 0/37 (0.00%)  0
Upper Respiratory Infection  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Urinary Tract Infection  1  3/36 (8.33%)  3 1/37 (2.70%)  1
Injury, poisoning and procedural complications     
Fracture  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Injury, poisoning and procedural complications  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Postoperative hemorrhage  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  3/36 (8.33%)  3 2/37 (5.41%)  2
Alkaline phosphatase increased  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Aspartate aminotransferase increased  1  3/36 (8.33%)  3 2/37 (5.41%)  2
Blood bilirubin increased  1  7/36 (19.44%)  7 4/37 (10.81%)  4
Cardiac troponin I increaesd  1  3/36 (8.33%)  3 0/37 (0.00%)  0
Neutrophil count decreased  1  15/36 (41.67%)  15 13/37 (35.14%)  13
Platelet count decreased  1  10/36 (27.78%)  10 4/37 (10.81%)  4
White blood cell decreased  1  10/36 (27.78%)  10 8/37 (21.62%)  8
Metabolism and nutrition disorders     
Dehydration  1  2/36 (5.56%)  2 1/37 (2.70%)  1
Hypokalemia  1  4/36 (11.11%)  4 1/37 (2.70%)  1
Hyperglycemia  1  0/36 (0.00%)  0 2/37 (5.41%)  2
Nervous system disorders     
Dizziness  1  2/36 (5.56%)  2 2/37 (5.41%)  2
Peripheral sensory  1  2/36 (5.56%)  2 0/37 (0.00%)  0
Transient ischemic attacks  1  2/36 (5.56%)  2 0/37 (0.00%)  0
Psychiatric disorders     
Confusion  1  4/36 (11.11%)  4 2/37 (5.41%)  2
Renal and urinary disorders     
Acute kidney injury  1  4/36 (11.11%)  4 1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  5/36 (13.89%)  5 1/37 (2.70%)  1
Respiratory failure  1  2/36 (5.56%)  2 1/37 (2.70%)  1
Vascular disorders     
Hypertension  1  2/36 (5.56%)  2 0/37 (0.00%)  0
Hypostension  1  1/36 (2.78%)  1 2/37 (5.41%)  2
Thromboembolic event  1  4/36 (11.11%)  4 3/37 (8.11%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Arm B (Carboplatin, Paclitaxel)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/36 (100.00%)      37/37 (100.00%)    
Blood and lymphatic system disorders     
Neutropenia  1  20/36 (55.56%)  20 22/37 (59.46%)  22
Leukopenia  1  12/36 (33.33%)  12 17/37 (45.95%)  17
Thrombocytopenia  1  10/36 (27.78%)  10 9/37 (24.32%)  9
Anemia  1  9/36 (25.00%)  9 11/37 (29.73%)  11
General disorders     
Fatigue  1  4/36 (11.11%)  4 3/37 (8.11%)  3
Infections and infestations     
Febrile Neutropenia  1  3/36 (8.33%)  3 4/37 (10.81%)  4
Infection  1  4/36 (11.11%)  4 2/37 (5.41%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 4.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne Noonan, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-685-6912
EMail: Anne.Noonan@osumc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01280058     History of Changes
Other Study ID Numbers: NCI-2011-02567
NCI-2011-02567 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU 10045
OSU-10045
CDR0000692060
8601 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
8601 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2011
First Posted: January 20, 2011
Results First Submitted: January 10, 2018
Results First Posted: February 7, 2018
Last Update Posted: March 9, 2018