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Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00090610
Recruitment Status : Completed
First Posted : August 31, 2004
Results First Posted : February 4, 2013
Last Update Posted : February 25, 2015
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Docetaxel
Drug: Carboplatin
Enrollment 150
Recruitment Details Between January 2004 and March 2007, 150 participants were enrolled at this multicenter study.
Pre-assignment Details All patients were assigned
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
Period Title: Overall Study
Started 75 75
Completed 74 74
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
63.8  (10.17) 64.9  (10.04) 63.9  (10.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
75
 100.0%
75
 100.0%
150
 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 75 participants 75 participants 150 participants
75 75 150
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description

Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression

Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease.

Time Frame Every 6 months, to 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient in each arm was excluded. The patient in Arm 1 did not complete 1 cycle of therapy. A patient in Arm 2 withdrew from the study
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
Overall Number of Participants Analyzed 74 74
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(9.9 to 16.8)
8.4
(7.1 to 11.0)
2.Secondary Outcome
Title Objective Response Rate
Hide Description

Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.

OR = CR + PR

Time Frame Every 6 months, starting at 12 months to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Same as for PFS
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.4
(43.4 to 67.0)
43.3
(31.8 to 55.3)
3.Secondary Outcome
Title Quality of Life
Hide Description

Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)

With these instruments, a higher score indicates better health-related quality of life.

Time Frame Baseline performed 14 days before first dose, then every other cycle and at study termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants was based on QoL data available for Arm 1 and one patient withdrew on Arm 2.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 76.3  (14.0) 76.6  (16.1)
Cycle 1 65.1  (21.3) 73.3  (16.2)
Cycle 2 72.7  (15.1) 75.3  (13.6)
Cycle 3 69.4  (13.5) 75.6  (12.8)
Cycle 4 70.8  (15.07) 76.0  (13.7)
Cycle 5 69.3  (14.5) 74.0  (16.2)
Cycle 6 74.3  (10.6) 81.2  (9.7)
End of Study 71.4  (15.0) 78.0  (14.8)
4.Secondary Outcome
Title Recurrence-Free Survival
Hide Description Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.
Time Frame Every 6 months starting at 12 months, to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who had a complete response.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
Overall Number of Participants Analyzed 13 9
Median (95% Confidence Interval)
Unit of Measure: months
20 [1] 
(13.8 to NA)
15.8
(10.4 to 25.4)
[1]
The upper bound cannot be estimated and is therefore considered unbounded.
5.Secondary Outcome
Title Median Overall Survival
Hide Description [Not Specified]
Time Frame Every 6 months starting at 12 months, to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
Overall Number of Participants Analyzed 74 74
Median (95% Confidence Interval)
Unit of Measure: months
33.2 [1] 
(32.4 to NA)
30.1
(29.3 to 43.9)
[1]
The upper bound cannot be estimated and is therefore considered unbounded.
Time Frame 7-70 weeks
Adverse Event Reporting Description Limited toxicity events including hematological, neurologic, hepatic, and renal toxicity were collected on the CRF. Other AEs were recorded in the patient’s medical chart. The SAEs were captured from the first dose of study medication through 30 days after the last administration of study medication.
 
Arm/Group Title Arm 1 Arm2
Hide Arm/Group Description Docetaxel 30 mg/m2 intravenously (IV) on Days 1 and 8, combined with carboplatin area under the concentration versus time curve (AUC) 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression (DP) (whichever occurred first). Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
All-Cause Mortality
Arm 1 Arm2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/75 (21.33%)      18/74 (24.32%)    
Blood and lymphatic system disorders     
Deep Thrombophlebitis  1  1/75 (1.33%)  1 1/74 (1.35%)  1
Cardiac disorders     
Pericardial Effusion  1  1/75 (1.33%)  1 0/74 (0.00%)  0
Heart Failure  1  0/75 (0.00%)  0 1/74 (1.35%)  1
Myocardial Infarct  1  0/75 (0.00%)  0 2/74 (2.70%)  2
Chest pain  1  3/75 (4.00%)  3 1/74 (1.35%)  1
Gastrointestinal disorders     
Intestinal obstruction  1  1/75 (1.33%)  1 7/74 (9.46%)  7
diarrhea  1  1/75 (1.33%)  1 0/74 (0.00%)  0
tongue edema  1  0/75 (0.00%)  0 1/74 (1.35%)  1
vomiting  1  0/75 (0.00%)  0 1/74 (1.35%)  1
Colitis  1  1/75 (1.33%)  1 0/74 (0.00%)  0
Pancreatitis  1  1/75 (1.33%)  1 0/74 (0.00%)  0
GI perforation  1  1/75 (1.33%)  1 0/74 (0.00%)  0
GI disorder  1  1/75 (1.33%)  1 0/74 (0.00%)  0
Ileus  1  1/75 (1.33%)  1 0/74 (0.00%)  0
Immune system disorders     
allergic reaction  1  1/75 (1.33%)  1 1/74 (1.35%)  1
Infections and infestations     
Infection  1  1/75 (1.33%)  1 3/74 (4.05%)  3
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/75 (1.33%)  1 0/74 (0.00%)  0
Nervous system disorders     
Cerebrovascular Accident  1  1/75 (1.33%)  1 0/74 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/75 (81.33%)      61/74 (82.43%)    
Blood and lymphatic system disorders     
Hematologic toxicity  1  61/75 (81.33%)  61/74 (82.43%) 
Hepatobiliary disorders     
Hepatic  1  11/75 (14.67%)  13/74 (17.57%) 
Nervous system disorders     
Neurotoxicity  1  25/75 (33.33%)  31/74 (41.89%) 
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 NOT 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
Name/Title: Angeles Alvarez Secord, Director of Gynecologic Oncology Clinical Trials
Organization: Duke University Medical Center
Phone: 919-684-3765
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00090610     History of Changes
Other Study ID Numbers: Pro00008381
DUKE UNIVERSITY MEDICAL CENTER ( Other Identifier: Duke UMC )
DUMC03
First Submitted: August 27, 2004
First Posted: August 31, 2004
Results First Submitted: November 21, 2012
Results First Posted: February 4, 2013
Last Update Posted: February 25, 2015