RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.

PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery.

Condition	Treatment or Intervention	Phase
Ovarian Cancer	Drug: carboplatin  Drug: cisplatin  Drug: cyclophosphamide  Drug: doxorubicin  Drug: paclitaxel	Phase III

Further Study Details: 

OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage III/IV ovarian cancer.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to size of tumor after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where treatment is received.

Within 14 days after patients undergo debulking surgery, they are randomized to one of two treatment arms.

Arm I: Patients randomized to this arm receive one of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B - cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D - carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F - carboplatin/paclitaxel

Arm II: Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery. If no valid assay result is obtained, patients receive carboplatin/cyclophosphamide.

Treatment is repeated every 3-4 weeks for a total of 6 courses. Up to 4 more courses may be administered if a partial response is demonstrated.

Patients are followed every 3 months for the first 2 years and every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.

Ages Eligible for Study:  up to  80 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically/pathologically confirmed stage III and IV ovarian cancer
• Complete surgical staging and debulking including total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and biopsies of suspicious lesions (if feasible) required
• No low malignant potential histology without any invasive lesions in the peritoneum

--Prior/Concurrent Therapy--

• See Disease Characteristics

--Patient Characteristics--

• Age: 80 and under
• Performance status: 0-3
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: No disorder that would prevent the application of any protocol treatment

Switzerland
      Burgerspital, Solothurn, Solothurn,  4500,  Switzerland
      City Hospital Triemli, Zurich,  8063,  Switzerland
      Frauenspital, Basel, Basel,  4031,  Switzerland
      Hopital Cantonal Universitaire de Geneva, Geneva,  CH-1211,  Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland
      Istituto Oncologico della Svizzera Italiana, Lugano,  CH-6900,  Switzerland
      Kantonspital Aarau, AARAU,  5001,  Switzerland
      Klinik Hirslanden, Zurich,  CH-8008,  Switzerland
      Office of Walter Weber-Stadelman, Basel,  CH 4051,  Switzerland
      University Hospital, Basel,  CH-4031,  Switzerland

Study chairs or principal investigators

O.R. Kochli,  Study Chair,  Swiss Institute for Applied Cancer Research   

Study ID Numbers:  CDR0000066074; SWS-SAKK-45/94; EU-97036
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003214
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08