S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer

• Status: Completed
• Trial end date: 2009-11-01
• 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 or combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer

• Adenocarcinoma

• Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion

• Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant metastases not allowed)

• No borderline or low-malignant potential tumors

• Optimal cytoreduction clinically deemed unlikely

• CA 125 at least 70 units/mL

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• SGOT no greater than 2 times ULN

Renal:

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No congestive heart failure or cardiac arrhythmia

• No myocardial infarction or angina within past 6 months

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding

• No grade 2 or greater sensory neuropathy

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

• No active or uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for this cancer

Chemotherapy:

• No prior chemotherapy for this cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic radiation for this cancer

Surgery:

• See Disease Characteristics

• Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy with omentectomy)

• Prior salpingo-oophorectomy and/or partial omentectomy allowed

Other:

• No other concurrent anti-cancer therapy