|Phase III||Treatment||Completed||18 and over||NCI, Other||CDR0000064554|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer.
Further Study Information
OBJECTIVES: I. Compare progression free and overall survival and frequency of response in patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin. II. Determine the incidence and severity of adverse events, including catheter complications and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and measurable disease (yes vs no). Patients are randomized into one of two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6 courses.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.
DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or primary peritoneal cancer Suboptimal residual disease within 6 weeks of laparotomy with maximum resection Stage III residual retroperitoneal disease greater than 1 cm and no greater than 1 cm residual intraperitoneal disease OR Stage IV disease The following histologies are eligible: Serous adenocarcinoma Malignant Brenner's tumor Mucinous adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Measurable disease not required Cytologic confirmation of malignant pleural effusion required if sole basis of entry No borderline (low malignant potential) carcinoma No unclassified ovarian cancer, i.e., thought to be of ovarian origin but unexplored or unable to verify tumor arising from ovarian stroma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST, ALT, and GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal LDH no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No history of congestive heart failure No history of unstable angina No myocardial infarction within 6 months Other: No severe infection, including septicemia No severe gastrointestinal bleeding No history of second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging laparotomy and primary cytoreductive surgery
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|David R. Spriggs||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002717
Information obtained from ClinicalTrials.gov on May 27, 2013
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