Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• 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. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.

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

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Carboplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed recurrent ovarian epithelial cancer after first line chemotherapy, unless clear evidence of clinically progressive disease

• Must have received prior first line chemotherapy consisting of at least 4 courses of either cisplatin or carboplatin

• At least 12 months since prior chemotherapy

• Measurable disease by clinical exam or diagnostic laparoscopy

• At least one lesion greater than 1 cm in diameter

• No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.25 times upper limit of normal (ULN)

• SGPT less than 2 times ULN

Renal:

• Creatinine less than 1.6 mg/dL OR

• Creatinine clearance greater than 40 mL/min

Other:

• No peripheral neurotoxicity greater than grade 2

• No psychological, familial, sociological, or geographical condition that would preclude study

• No complete bowel obstruction

• No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No more than 1 prior regimen of chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics