Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for treating ovarian epithelial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with that of carboplatin plus docetaxel in treating patients who have ovarian epithelial cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Glasgow
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Docetaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IC-IV ovarian epithelial cancer IC must have malignant cells in ascitic fluid or peritoneal washing, have tumor on surface of the ovary, or have preoperative capsule rupture OR Peritoneal carcinomatosis (ovarian-type) No evidence of primary fallopian tube carcinoma No mixed mesodermal tumors No borderline ovarian tumors or tumors termed possibly malignant

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) OR ALT or AST no greater than 1.5 times ULN OR Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No hypertension No ischemic heart disease No myocardial infarction within the past 6 months No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No other concurrent severe and/or uncontrolled comorbid medical condition No prior malignancy within the past 5 years, except: Curatively treated carcinoma in situ of the cervix Basal cell skin cancer No other concurrent malignancy (e.g., endometrial cancer) No prior serious allergic reaction (e.g., anaphylactic shock) No symptomatic grade 2 or greater peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior surgery allowed