Phase II Master Protocol Study of Chemotherapeutic Agents in the Treatment of Recurrent or Advanced Uterine Sarcomas --- IFF plus Mesna
Basic Trial Information
|Phase II||Treatment||Completed||18 and over||NCI||GOG-87B|
I. Identify new agents and combinations of agents for treating recurrent or metastatic sarcoma of the uterus. II. Determine, in this portion of the master protocol, the efficacy of ifosfamide in combination with the uroprotector mesna in patients who have had no prior cytotoxic drug therapy.
Histologically confirmed uterine sarcoma that is advanced, persistent, or recurrent, progressive after appropriate local therapy and considered incurable Bidimensionally measurable abdominal, pelvic, chest, or other mass defined by palpation, x-ray, CT, or ultrasound required
Biologic therapy: Not specified Chemotherapy: No prior cytotoxic drugs Endocrine therapy: Not specified Radiotherapy: Recovery from recent radiotherapy required Surgery: Recovery from recent surgery required
Age: 18 and over Performance status: GOG 0-2 (Karnofsky 50-100%) Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 x normal SGOT no greater than 3 x normal Alkaline phosphatase no greater than 3 x normal Albumin at least 3.0 g/dl Renal: Creatinine no greater than 2.0 mg/dl Other: No clinically significant infection No prior or concomitant malignancy except nonmelanomatous skin cancer
30 evaluable patients/histologic category will be required. As of June 1989, the study is closed to patients with leiomyosarcoma.
Nonrandomized study. Single-Agent Chemotherapy plus Bladder Protection. Ifosfamide, IFF, NSC-109724; plus Mercaptoethane sulfonate, Mesna, NSC-113891.
Sutton GP, Blessing JA, Rosenshein N, et al.: Phase II trial of ifosfamide and mesna in mixed mesodermal tumors of the uterus (a Gynecologic Oncology Group study). Am J Obstet Gynecol 161 (2): 309-12, 1989.[PUBMED Abstract]
Sutton G, Blessing J, McGuire W, et al.: Phase II trial of ifosfamide and MESNA in patients with recurrent or advanced mixed mesodemal tumors of the uterus. [Abstract] Proceedings of the American Society of Clinical Oncology 7: A-529, 137, 1988.
Sutton GP, Blessing JA, Photopulos G, et al.: Early phase II Gynecologic Oncology Group experience with ifosfamide/mesna in gynecologic malignancies. Cancer Chemother Pharmacol 26 (Suppl): S55-8, 1990.[PUBMED Abstract]
Sutton GP, Blessing JA, Photopulos G, et al.: Phase II experience with ifosfamide/mesna in gynecologic malignancies: preliminary report of Gynecologic Oncology Group studies. Semin Oncol 16 (1 Suppl 3): 68-72, 1989.[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.