Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage 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 may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

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

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types:

• Serous adenocarcinoma

• Malignant Brenner's tumor

• Mucinous adenocarcinoma

• Endometrioid

• Adenocarcinoma

• Clear cell adenocarcinoma

• Undifferentiated carcinoma

• Transitional cell

• Mixed epithelial carcinoma

• Adenocarcinoma - not otherwise specified

• Meets 1 of the following criteria:

• Stage Ia or Ib, grade 3 or clear cell

• Stage Ic or II, all grades/histologies

• Complete surgical staging

• No tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

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

Hepatic:

• Bilirubin no greater than 1.5 times normal

• Alkaline phosphatase no greater than 3 times normal

• SGOT no greater than 3 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

• No major systemic medical illness expected to affect survival

• Body surface area no greater than 2.0

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• No prior treatment for this malignancy except surgical staging

• No prior anticancer therapy that would preclude study participation