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Phase II Study of CDDP/CBDCA with Ondansetron or Granisetron and G-CSF in Patients with Stage III/IV Epithelial Ovarian Cancer
Basic Trial Information
Objectives I. Determine whether double platinum therapy with cisplatin and carboplatin offers any significant improvement in frequency of objective response (clinical and pathological), progression-free interval, and duration of survival over prior regimens for patients with Stage III/IV epithelial ovarian cancer. II. Evaluate the toxicity of double platinum therapy, and determine whether newer antiemetic therapy with ondansetron or granisetron and growth factor therapy with granulocyte colony stimulating factor can decrease the known toxicities of this regimen. Entry Criteria Disease Characteristics: Histologically confirmed, Stage III/IV epithelial adenocarcinoma of the ovary Appropriate surgery required, with appropriate tissue submitted for histologic exam Measurable or evaluable disease required, including CA-125 levels Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No more than 4 weeks since surgery Patient Characteristics: Age: Not specified Performance status: ECOG 0-2 Hematopoietic: AGC at least 1,000 Platelets at least 100,000 Hepatic: (in the absence of tumor involvement) Bilirubin less than 2 x normal SGOT less than 2 x normal Alkaline phosphatase less than 2 x normal Renal: Creatinine less than 2.0 mg/dl Other: No serious active infection requiring antibiotics No major organ allografts No second malignancy within the last 5 years except nonmelanomatous skin cancer Expected Enrollment Up to 30 patients will be entered over 24 months. If no responses are seen in the first 14 evaluable patients, the study will be terminated. Outline 2-Drug Combination Chemotherapy with Antiemetic Prophylaxis and Hematologic Toxicity Attenuation. Cisplatin, CDDP, NSC-119875; Carboplatin, CBDCA, NSC-241240; with Ondansetron or Granisetron (Kytril); and Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629.Published Results Hall DJ, Kincaid K: Phase II trial of Cisplatin and Paraplatin in stages III and IV epithelial ovarian cancer: National Biotherapy Study Group protocol. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-795, 281, 1995. Trial Lead Organizations Cancer Biotherapy Research Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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