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A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

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Trial Information

A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with
persistent or recurrent, refractory endometrial carcinoma. II. Determine the nature and
degree of toxicity of this treatment in these patients.

OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5
minutes on days 1-4. Treatment continues every 28 days in the absence of disease progression
or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6
months for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma refractory to
curative therapy or established treatments Clinically or histologically confirmed
persistent or recurrent disease Bidimensionally measurable disease (ascites or pleural
effusions not considered measurable) Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at
least 1,500/mm3 Hepatic: Bilirubin normal Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min Cardiovascular: No clinically uncontrolled
dysrhythmia or signs of ischemia per ECG No congestive heart failure requiring medication
No uncontrolled hypertension Other: No significant active infection No other prior or
concurrent malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen allowed
(either single or combination cytotoxic drug therapy) No prior 6-hydroxymethylacylfulvene
No prior chemotherapy for other malignancy Endocrine therapy: Not specified Radiotherapy:
At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy for other
malignancy Surgery: At least 3 weeks since prior surgery and recovered

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Chao Family Comprehensive Cancer Center Orange, California  92868
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Tacoma General Hospital Tacoma, Washington  98405
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Community Hospital of Los Gatos Los Gatos, California  95032
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Tufts University School of Medicine Boston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Brookview Research, Inc. Nashville, Tennessee  37203
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Radiation Oncology Branch Bethesda, Maryland  20892
Ellis Fischel Cancer Center Columbia, Missouri  65203