High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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 most effective for ovarian epithelial cancer.

PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery.

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

Details

• Lead Sponsor: EBMT Solid Tumors Working Party
• Treatments: Carboplatin; Cyclophosphamide; Melphalan; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III or IV ovarian epithelial cancer

• Bilateral salpingo-oophorectomy, hysterectomy, and omentectomy within 6 weeks of study

• Less than 2 cm maximum diameter of residual tumor remaining

PATIENT CHARACTERISTICS:

Age:

• 18 to 65

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Normal hematological function

Hepatic:

• Normal hepatic function

Renal:

• Creatinine clearance greater than 60 mL/min

• GFR greater than 60 mL/min

Cardiovascular:

• No active cardiac disease

Other:

• No other uncontrolled serious medical illness, including hearing problems

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics