EUCTR2007-007849-13-ITActive, not recruitingNot Applicable
Randomized Phase III Trial of Paclitaxel plus Carboplatin (TC) Therapy versus Irinotecan plus Cisplatin (CPT-P) Therapy as a First Line Chemotherapy for Clear Cell Carcinoma of the Ovary - GCIG/JGOG3017
Japanese Gynecologic Oncology Group (JGOG)0 sites652 target enrollmentStarted: July 22, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 652
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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) after registration. (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 1xULN to 1.5 x ULN, she must have creatinine clearance≧60 ml/min * Creatinine clearance should be calculated using the Modified Jelliffe formula (see section 5.2 of the protocol) 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) 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 are: Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided 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 are: 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) Patients with diarrhea greater than CTCAE grade 1 (Grade 2, 3, and 4) 9) Patients with an active infection which requires antibiotics. 10) Patients with 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 (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months. 12) Patients with bowel obstruction. 13) Patients with interstitial pneumonitis. 14) Patients with massive pleural effusion and/or ascites. 15) Patients who are under treatment with Atazanavir 16) Patients with known hypersensitivity to polyoxyethylated castor oil or any of four chemotherapeutic agents (Paclitaxel, Carboplatin, Irinotecan, and Cisplatin). 17) Patients who are pregnant or lactating. 18) Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow-up.
Investigators
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