Clinical trial NCT00226915: Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Keywords: ovarian neoplasms
randomized controlled trial
paclitaxel
carboplatin
Lead sponsor: Japanese Gynecologic Oncology Group
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 637
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Progression Free Suvaival
timeFrame: During the protocol treatment then 18 months from the last day of the protocol treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: During the protocol treatment then 18 months from the last day of the protocol treatment
measure: QOL
timeFrame: During the protocol treatment then 18 months
measure: Adverse Event
timeFrame: During the protocol treatment then 18 months
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
affiliation: The Jikei University School of Medicine
name: Makoto Yasuda, M.D.
role: STUDY_CHAIR
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