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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
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Completed any age NCI GOG-108
GOG-0108

Objectives

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.

Entry Criteria

Disease Characteristics:


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

Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Not specified

Patient Characteristics:


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

Expected Enrollment

84 patients per treatment arm will be entered; the anticipated annual accrual 
is 35 patients.

Outline

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.

Published Results

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

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.