Overview

Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer

Status:
Completed
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. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically proven primary peritoneal carcinoma or optimal (no
greater than 1 cm residual disease) stage III epithelial ovarian carcinoma with the
following epithelial cell types: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous
adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial
carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Adenocarcinoma NOS Prior
surgery for ovarian/peritoneal carcinoma required No epithelial ovarian carcinoma of low
malignant potential (borderline carcinoma)

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no
greater than 2.0 mg/dL Cardiovascular: No unstable angina No myocardial infarction within
prior 6 months Patients with abnormal cardiac conduction are eligible if disease stable for
at least 6 months Other: No septicemia or severe infection No severe gastrointestinal
bleeding No other invasive malignancy within past 5 years except nonmelanoma skin cancer
Any previous cancer treatment must not contraindicate this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics No more than 6 weeks since prior surgery