Phase II Master Protocol Study of Chemotherapeutic Agents in the Treatment of Recurrent or Advanced Uterine Sarcomas --- IFF plus Mesna

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 and overNCIGOG-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.

Entry Criteria

Disease Characteristics:

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

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

  No prior cytotoxic drugs

Endocrine therapy:
  Not specified

  Recovery from recent radiotherapy required

  Recovery from recent surgery required

Patient Characteristics:

  18 and over

Performance status:
  GOG 0-2 (Karnofsky 50-100%)

  WBC at least 3,000
  AGC at least 1,500
  Platelets at least 100,000

  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

  Creatinine no greater than 2.0 mg/dl

  No clinically significant infection
  No prior or concomitant malignancy except nonmelanomatous
     skin cancer

Expected Enrollment

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.

Published Results

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.

Related Publications

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

Gregory Sutton, MD, Protocol chair (Contact information may not be current)
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.