clear cell carcinoma of the ovary
Conditions
Interventions
Paclitaxel 175 mg/m2 day 1+ Carboplatin AUC 6 day 1 q 3 weeks 6 cycles
Irinotecan 60 mg/m2 day 1,8,15+ Cisplatin 60 mg/m2 day 1 q 4 weeks 6 cycles
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with a histological diagnosis of clear cell carcinoma of the ovary, FIGO Stages I to IV. All patients must have had appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. In the case with concurrent presence of other histological cell types, clear cell histology must be dominant ( > 50%). The histological diagnosis will be confirmed by a central pathology review (CPR) (Three pathology slides required.) 2) Age: 18 or older 3) ECOG Performance Status: 0 - 1 4) Reasonable organ function: Must be assessed within 14 days prior to randomization. Absolute Neutrophil Count: 1,500 / mm3 or more Platelet: 100,000 / mm3 or more Renal Function: Serum creatinine should be 1.5 x institutional ULN or less. If patient has serum creatinine of 1 x ULN to 1.5 x ULN, she must have creatinine clearance > 60 ml/min * Creatinine clearance should be calculated using the Modified Jelliffe formula Hepatic Function: Bilirubin less than or equal to 1.5 x institutional ULN ( < CTCAE grade 1). AST (SGOT) and alkaline phosphatase less than or equal to 2.5 x institutional ULN ( < CTCAE grade 1). Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE grade 1. 5) Patient must have signed informed consent. 6) Patients must be enrolled within 6 weeks after comprehensive staging surgery.
Exclusion criteria
Exclusion criteria: 1) Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential 2) Patients with other malignancies including synchronous primary endometrial cancer or a past history of primary endometrial cancer 3) Patients who have received prior chemotherapy or radiation therapy to treat the current disease 4) Patients who received intraperitoneal chemotherapy at the time of operation 5) Patients with a prior diagnosis of malignancy are not eligible. Exceptions are: - stage 0 endometrial cancer - carcinoma in situ of the cervix - non-melanoma skin cancer - other malignancies curatively treated and > 5 years without evidence of recurrence 6) Patients who have received prior radiotherapy Exceptions Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease. 7) Patients who have received prior chemotherapy. Exceptions Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and that the patient remains free of recurrent or metastatic disease. 8,9,10) Patients with diarrhea greater than CTCAE grade1, active infection that requires antibiotics, ongoing gastrointestinal bleeding requiring blood product support 11) Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months. 12,13,14,16) Patients with bowel obstruction, interstitial pneumonitis, massive pleural effusion and/or ascites, known hypersensitivity to polyoxyethylated castor oil or any of four chemotherapeutic agents 15,17,18) Patients who are under treatment with Atazanavir, pregnant or lactating, would not permit completion of study or required follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression - Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival,Response Rate,Adverse Event | — |
Countries
Japan,Asia(except Japan),Europe
Contacts
Public ContactToru Sugiyama ,M.D.,Ph.D.
GCIG/JGOG3017 Office Iwate Medical University, School of Medicine, Department of Obsterics and Gynecology
Outcome results
None listed