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Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00005031
Collaborator
National Cancer Institute (NCI) (NIH)
40
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have persistent or recurrent refractory endometrial cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date :
Aug 1, 2000
Actual Primary Completion Date :
Oct 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Community Hospital of Los Gatos Los Gatos California United States 95032
    3 Chao Family Comprehensive Cancer Center Orange California United States 92868
    4 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    5 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    6 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    7 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    8 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    9 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    10 Radiation Oncology Branch Bethesda Maryland United States 20892
    11 Tufts University School of Medicine Boston Massachusetts United States 02111
    12 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    13 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    14 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    15 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    16 Ellis Fischel Cancer Center Columbia Missouri United States 65203
    17 Washington University School of Medicine Saint Louis Missouri United States 63110
    18 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    19 Cancer Center of Albany Medical Center Albany New York United States 12208
    20 University of Rochester Cancer Center Rochester New York United States 14642
    21 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    22 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    23 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    24 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    25 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    26 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    27 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    28 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    29 Abington Memorial Hospital Abington Pennsylvania United States 19001
    30 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    31 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    32 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    33 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    34 Brookview Research, Inc. Nashville Tennessee United States 37203
    35 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    36 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    37 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    38 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    39 Tacoma General Hospital Tacoma Washington United States 98405
    40 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Russell J. Schilder, MD, Fox Chase Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00005031
    Other Study ID Numbers:
    • CDR0000067554
    • GOG-129L
    First Posted:
    Mar 31, 2004
    Last Update Posted:
    May 27, 2013
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    recurrent endometrial carcinoma
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Irofulven

    Study Results

    No Results Posted as of May 27, 2013