Overview

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