Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Objectives

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

Chemotherapy:
  No prior cytotoxic drugs

Endocrine therapy:
  Not specified

Radiotherapy:
  Recovery from recent radiotherapy required

Surgery:
  Recovery from recent surgery required

Patient Characteristics:

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

Expected Enrollment

30 evaluable patients/histologic category will be required.  As of June 1989, 
the study is closed to patients with leiomyosarcoma.

Outline

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

Gregory Sutton, MD, Protocol chair (Contact information may not be current)		Ph: 317-278-4822; 888-600-4822

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