High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
Condition: Ovarian Cancer
MeSH terms: Ovarian 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 which chemotherapy regimen is most effective for ovarian epithelial cancer.

      PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well
      it works compared to standard chemotherapy in treating patients with stage III or stage IV
      ovarian epithelial cancer that has been removed during surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the two-year progression-free survival in patients with optimally debulked stage
           III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs
           standard chemotherapy.

        -  Compare the overall survival, toxicity, and quality of life in this patient population
           receiving these two treatment regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive 5 courses of sequential high-dose chemotherapy as follows:

             -  Courses 1 and 2: Patients receive paclitaxel IV over 3 hours and cyclophosphamide
                IV over 2 hours on day 1 followed by peripheral blood stem cell (PBSC) collection.
                Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours
                following chemotherapy and continuing until target number of PBSC are reached.

             -  Courses 3 and 4: Patients receive paclitaxel as in courses 1-2 and carboplatin IV
                over 4 hours on day 1. At 72 hours following completion of carboplatin, patients
                receive PBSC infusion. Beginning one day following PBSC infusion, patients receive
                G-CSF SC until blood counts recover.

             -  Course 5: Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in
                courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3. Patients receive
                PBSC and G-CSF as in courses 3 and 4.

             -  Treatment repeats every 3-4 weeks.

        -  Arm II: Patients receive standard chemotherapy consisting of carboplatin (or cisplatin)
           and paclitaxel IV over 3 hours every 3 weeks for 6 courses. Patients may receive
           doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks.

      Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy,
      and then at 3 months, 9 months, and 15 months.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): filgrastim; carboplatin; cyclophosphamide; melphalan; paclitaxel; adjuvant therapy; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Melphalan
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer