Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
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 and giving the drugs in different
      combinations may kill more tumor cells. It is not yet known which combination chemotherapy
      regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian
      tube cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of different combination
      chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian
      epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin
           vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients
           with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian
           tube cancer.

        -  Compare the overall survival of patients treated with these regimens.

        -  Compare the clinical objective response rates in patients with measurable disease at
           baseline treated with these regimens.

        -  Compare the toxic effects of these regimens in these patients.

        -  Compare the CA 125 normalization rates in patients treated with these regimens.

        -  Compare the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center, age (65 years and under vs over 65 years), and pre-randomization
      surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs
      debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic
      residual disease). Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30
           minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV
           over 30 minutes on day 1 of courses 5-8.

        -  Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
           on day 1 of courses 1-8.

      In both arms, courses repeat every 21 days in the absence of disease progression or
      unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4.

      Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the
      last course; and at 3 and 6 months after study treatment completion.

      Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
      study within 2 years.
    

Intervention name(s): carboplatin; cisplatin; paclitaxel; topotecan hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle; 4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle; Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle; 4 cycles
.75mg/m2 (30 mins) days 1-5 of 21 day cycle
Intervention MeSH terms: Paclitaxel; Carboplatin; Topotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer