Overview

This trial is active, not recruiting.

Conditions epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer
Treatments paclitaxel+carboplatin
Phase phase 3
Sponsor Japanese Gynecologic Oncology Group
Start date April 2003
End date June 2012
Trial size 637 participants
Trial identifier NCT00226915, C000000183 (by UMIN), JGOG3016

Summary

The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Drug: Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
paclitaxel+carboplatin
Paclitaxel 180mg/m2+CBDCA AUC6 q21 days x 6-9cycles
(Experimental)
Drug: Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles
paclitaxel+carboplatin
Paclitaxel 80mg/m2 weekly +CBDCA AUC6 q21 days x 6-9cycles

Primary Outcomes

Measure
Progression Free Suvaival
time frame: During the protocol treatment then 18 months from the last day of the protocol treatment

Secondary Outcomes

Measure
Overall Survival
time frame: During the protocol treatment then 18 months from the last day of the protocol treatment
Adverse Event
time frame: During the protocol treatment then 18 months
Quality of life
time frame: During the protocol treatment then 18 months

Eligibility Criteria

Female participants at least 20 years old.

Inclusion Criteria: - Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer - No prior chemotherapy - Age: 20 and more - Performance status: ECOG 0-3 - 1) Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL - Written informed consent Exclusion Criteria: - Patients with ovarian borderline tumor - Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy - Patients with active infection or uncontrolled diabetes - Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication - Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)

Additional Information

Official title Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma
Description This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or others). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles. Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles. In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles. PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Japanese Gynecologic Oncology Group.