Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 3

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 if paclitaxel plus carboplatin is more effective with or without topotecan for
      ovarian epithelial cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus
      carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or
      stage IV ovarian epithelial cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial
      carcinoma after receiving treatment with paclitaxel and carboplatin with or without
      topotecan. II. Compare progression-free survival of these patients after receiving these
      treatment regimens. III. Compare the response rate and response duration in these patients
      treated with these regimens. IV. Determine the toxic effects of the combination of
      paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of
      these treatment regimens in these patients. VI. Compare quality of life of these patients
      treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center and stage (stage IIB and stage III optimally debulked to no greater than
      1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1
      cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel
      IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over 0.5 hour on
      days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is administered for 4
      courses only). Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment
      repeats every 21 days for 6 courses. Quality of life is assessed before courses 1, 3, and 5
      and at 3 weeks and 3 months after completion of treatment in both treatment arms; before
      courses 1 and 3 of topotecan in arm I; and at 6 months after completion of treatment in arm
      II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this
      study over 2 years.
    

Intervention name(s): carboplatin; paclitaxel; topotecan hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin; Topotecan
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer