Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: carboplatin; paclitaxel
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 571.0
Sex: Female
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; ovarian undifferentiated adenocarcinoma; ovarian mixed epithelial carcinoma; ovarian serous cystadenocarcinoma; ovarian mucinous cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian clear cell cystadenocarcinoma; Brenner tumor

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.
    

Eligibility 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