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Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00193037
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : July 19, 2013
Last Update Posted : July 31, 2013
Sponsor:
Collaborators:
Ortho Biotech, Inc.
Aventis Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Liposomal Doxorubicin
Drug: Docetaxel
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A -Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Hide Arm/Group Description

Liposomal doxorubicin (Arm A)

Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.

Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria.

Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.

Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.

Period Title: Randomized Treatment
Started 50 52
Completed 32 24
Not Completed 18 28
Period Title: Crossover Treatment
Started 32 24
Completed 32 24
Not Completed 0 0
Arm/Group Title Arm A -Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin Total
Hide Arm/Group Description

Liposomal doxorubicin (Arm A)

Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.

Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.

Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.

Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.

Total of all reporting groups
Overall Number of Baseline Participants 50 52 102
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 52 participants 102 participants
62
(31 to 87)
62
(31 to 87)
62
(31 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
Female
50
 100.0%
52
 100.0%
102
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 52 participants 102 participants
50 52 102
1.Primary Outcome
Title Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Hide Description ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were removed from treatment before evaluation were not included in analysis
Arm/Group Title Arm A -Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Hide Arm/Group Description:

Liposomal doxorubicin (Arm A)

Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.

Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.

Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.

Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.

Overall Number of Participants Analyzed 42 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
28
(16 to 42)
31
(18 to 45)
2.Secondary Outcome
Title Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
Hide Description PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A -Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Hide Arm/Group Description:

Liposomal doxorubicin (Arm A)

Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.

Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.

Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.

Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.

Overall Number of Participants Analyzed 48 44
Median (95% Confidence Interval)
Unit of Measure: months
6.5
(3.6 to 9.5)
5.5
(4.9 to 9.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A - Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Hide Arm/Group Description Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria. Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
All-Cause Mortality
Arm A - Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A - Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/50 (36.00%)      22/52 (42.31%)    
Cardiac disorders     
Hypotension  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Bradycardia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Cardiac Arrest  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Pain - Abdominal  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hemorrhage - GI  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Vomiting  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Nausea  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Dehydration  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Diverticular Abscess  1  1/50 (2.00%)  1 0/52 (0.00%)  0
General disorders     
Failure to Thrive  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Fever  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Hepatobiliary disorders     
Liver Dysfunction  1 [1]  1/50 (2.00%)  1 1/52 (1.92%)  1
Infections and infestations     
Febrile Neutropenia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Metabolism and nutrition disorders     
Hypoglycemia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hyperglycemia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hypokalemia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders     
Pain - Bone  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Fracture  1 [2]  1/50 (2.00%)  1 0/52 (0.00%)  0
Pain - Musculoskeletal  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Progressive Disease  1  4/50 (8.00%)  4 5/52 (9.62%)  5
Nervous system disorders     
Syncope  1  0/50 (0.00%)  0 1/52 (1.92%)  1
CNS Ischemia  1 [3]  1/50 (2.00%)  1 0/52 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Dyspnea  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Pneumothorax  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Vascular disorders     
Thrombosis/Thrombus/Embolism  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Superior Vena Cava Syndome  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Jaundice
[2]
Subtrochanteric Fracture
[3]
Cerebrovascular Accident (CVA)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A - Liposomal Doxorubicin Then Docetaxel Arm B - Docetaxel Then Liposomal Doxorubicin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/50 (42.00%)      35/52 (67.31%)    
Blood and lymphatic system disorders     
Neutrophils  1  5/50 (10.00%)  5 1/52 (1.92%)  1
Edema  1  0/50 (0.00%)  0 4/52 (7.69%)  4
Cardiac disorders     
Hypotension  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Gastrointestinal disorders     
Mucositis/Stomatitis  1  4/50 (8.00%)  4 3/52 (5.77%)  3
Nausea/Vomiting  1  2/50 (4.00%)  2 6/52 (11.54%)  6
General disorders     
Fatigue  1  3/50 (6.00%)  3 13/52 (25.00%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia/Myalgia  1  2/50 (4.00%)  2 5/52 (9.62%)  5
Skin and subcutaneous tissue disorders     
Hand-Foot  1  5/50 (10.00%)  5 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 615-329-7274
EMail: jhainsworth@tnonc.com
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193037     History of Changes
Other Study ID Numbers: SCRI BRE 43
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: August 22, 2012
Results First Posted: July 19, 2013
Last Update Posted: July 31, 2013