Trial Outcomes & Findings for Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer (NCT NCT00090610)

Last Updated: 2015-02-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

Every 6 months, to 18 months

Results posted on

2015-02-25

Participant Flow

Between January 2004 and March 2007, 150 participants were enrolled at this multicenter study.

All patients were assigned

Participant milestones

Participant milestones
Measure	Arm 1 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	Arm 2 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 Study STARTED	75	75
Overall Study COMPLETED	74	74
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 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	Arm 2 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 Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=75 Participants 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	Arm 2 n=75 Participants 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 n=150 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 10.17 • n=5 Participants	64.9 years STANDARD_DEVIATION 10.04 • n=7 Participants	63.9 years STANDARD_DEVIATION 10.08 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 6 months, to 18 months

Population: 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

Outcome measures

Outcome measures
Measure	Arm 1 n=74 Participants 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	Arm 2 n=74 Participants 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.
Progression-free Survival (PFS)	13.7 months Interval 9.9 to 16.8	8.4 months Interval 7.1 to 11.0

SECONDARY outcome

Timeframe: Every 6 months, starting at 12 months to 24 months

Population: Same as for PFS

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

Outcome measures

Outcome measures
Measure	Arm 1 n=74 Participants 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	Arm 2 n=74 Participants 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.
Objective Response Rate	55.4 percentage of participants Interval 43.4 to 67.0	43.3 percentage of participants Interval 31.8 to 55.3

SECONDARY outcome

Timeframe: Baseline performed 14 days before first dose, then every other cycle and at study termination

Population: The number of participants was based on QoL data available for Arm 1 and one patient withdrew on Arm 2.

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=74 Participants 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	Arm 2 n=74 Participants 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.
Quality of Life Baseline	76.3 units on a scale Standard Deviation 14.0	76.6 units on a scale Standard Deviation 16.1
Quality of Life Cycle 1	65.1 units on a scale Standard Deviation 21.3	73.3 units on a scale Standard Deviation 16.2
Quality of Life Cycle 2	72.7 units on a scale Standard Deviation 15.1	75.3 units on a scale Standard Deviation 13.6
Quality of Life Cycle 3	69.4 units on a scale Standard Deviation 13.5	75.6 units on a scale Standard Deviation 12.8
Quality of Life Cycle 4	70.8 units on a scale Standard Deviation 15.07	76.0 units on a scale Standard Deviation 13.7
Quality of Life Cycle 5	69.3 units on a scale Standard Deviation 14.5	74.0 units on a scale Standard Deviation 16.2
Quality of Life Cycle 6	74.3 units on a scale Standard Deviation 10.6	81.2 units on a scale Standard Deviation 9.7
Quality of Life End of Study	71.4 units on a scale Standard Deviation 15.0	78.0 units on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: Every 6 months starting at 12 months, to 24 months

Population: Subjects who had a complete response.

Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.

Outcome measures

Outcome measures
Measure	Arm 1 n=13 Participants 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	Arm 2 n=9 Participants 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.
Recurrence-Free Survival	20 months Interval 13.8 to The upper bound cannot be estimated and is therefore considered unbounded.	15.8 months Interval 10.4 to 25.4

SECONDARY outcome

Timeframe: Every 6 months starting at 12 months, to 24 months

Outcome measures

Outcome measures
Measure	Arm 1 n=74 Participants 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	Arm 2 n=74 Participants 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.
Median Overall Survival	33.2 months Interval 32.4 to The upper bound cannot be estimated and is therefore considered unbounded.	30.1 months Interval 29.3 to 43.9

Adverse Events

Arm 1

Serious events: 16 serious events

Other events: 61 other events

Deaths: 0 deaths

Arm2

Serious events: 18 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm 1 n=75 participants at risk 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).	Arm2 n=74 participants at risk 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.
Blood and lymphatic system disorders Hematologic toxicity	81.3% 61/75 • 7-70 weeks 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.	82.4% 61/74 • 7-70 weeks 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.
Nervous system disorders Neurotoxicity	33.3% 25/75 • 7-70 weeks 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.	41.9% 31/74 • 7-70 weeks 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.
Hepatobiliary disorders Hepatic	14.7% 11/75 • 7-70 weeks 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.	17.6% 13/74 • 7-70 weeks 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.

Additional Information

Angeles Alvarez Secord, Director of Gynecologic Oncology Clinical Trials

Duke University Medical Center

Phone: 919-684-3765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1 n=75 participants at risk 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).	Arm2 n=74 participants at risk 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.
Gastrointestinal disorders Intestinal obstruction	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	9.5% 7/74 • Number of events 7 • 7-70 weeks 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.
Immune system disorders allergic reaction	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	1.4% 1/74 • Number of events 1 • 7-70 weeks 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.
Gastrointestinal disorders diarrhea	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Gastrointestinal disorders tongue edema	0.00% 0/75 • 7-70 weeks 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.	1.4% 1/74 • Number of events 1 • 7-70 weeks 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.
Gastrointestinal disorders vomiting	0.00% 0/75 • 7-70 weeks 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.	1.4% 1/74 • Number of events 1 • 7-70 weeks 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.
Infections and infestations Infection	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	4.1% 3/74 • Number of events 3 • 7-70 weeks 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.
Blood and lymphatic system disorders Deep Thrombophlebitis	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	1.4% 1/74 • Number of events 1 • 7-70 weeks 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.
Cardiac disorders Pericardial Effusion	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Cardiac disorders Heart Failure	0.00% 0/75 • 7-70 weeks 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.	1.4% 1/74 • Number of events 1 • 7-70 weeks 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.
Cardiac disorders Myocardial Infarct	0.00% 0/75 • 7-70 weeks 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.	2.7% 2/74 • Number of events 2 • 7-70 weeks 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.
Gastrointestinal disorders Colitis	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Gastrointestinal disorders Pancreatitis	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Gastrointestinal disorders GI perforation	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Gastrointestinal disorders GI disorder	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Musculoskeletal and connective tissue disorders Arthritis	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Nervous system disorders Cerebrovascular Accident	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Gastrointestinal disorders Ileus	1.3% 1/75 • Number of events 1 • 7-70 weeks 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.	0.00% 0/74 • 7-70 weeks 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.
Cardiac disorders Chest pain	4.0% 3/75 • Number of events 3 • 7-70 weeks 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.	1.4% 1/74 • Number of events 1 • 7-70 weeks 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.