Phase III Study of IFF and the Uroprotector Mesna Administered Alone or with CDDP in Patients with Advanced or Recurrent Mixed Mesodermal Tumors of the Uterus
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||GOG-108|
I. Confirm, in a randomized Phase III setting, reported high response rates of advanced or recurrent mixed mesodermal tumors of the uterus to ifosfamide (IFF) plus mesna. II. Determine whether the addition of cisplatin (CDDP) to IFF/mesna improves response rates or survival in patients with these tumors. III. Determine the toxicity of CDDP/IFF/mesna in patients with these tumors.
Histologically confirmed advanced, persistent, or recurrent, primary heterologous or homologous (carcinosarcoma) mixed mesodermal tumors of the uterus Disease of the abdomen, pelvis, chest, or other location that is bidimensionally measurable by palpation, x-ray, CT, or ultrasound required No extensive hepatic metastases
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dl SGOT no greater than 3 x normal Albumin at least 3 g/dl No acute hepatitis Renal: Creatinine no more than 1.5 mg/dl OR Creatinine clearance at least 50 ml/min Other: No septicemia or severe infection No gastrointestinal bleeding No second malignancy except nonmelanomatous skin cancer
84 patients per treatment arm will be entered; the anticipated annual accrual is 35 patients.
Randomized study. Arm I: Single-Agent Chemotherapy with Uroprotection. Ifosfamide, IFF, NSC-109724; with Mesna, NSC-113891. Arm II: 2-Drug Combination Chemotherapy with Uroprotection. Cisplatin, CDDP, NSC-119875; IFF; with Mesna.
Sutton G, Brunetto VL, Kilgore L, et al.: A phase III trial of ifosfamide with or without cisplatin in carcinosarcoma of the uterus: A Gynecologic Oncology Group Study. Gynecol Oncol 79 (2): 147-53, 2000.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Gynecologic Oncology Group
Ph: 317-278-4822; 888-600-4822
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.