Back to resultsIrofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
irofulven
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Community Hospital of Los Gatos
- Chao Family Comprehensive Cancer Center
- Walter Reed Army Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Rush-Presbyterian-St. Luke's Medical Center
- University of Chicago Cancer Research Center
- Indiana University Cancer Center
- Holden Comprehensive Cancer Center at The University of Iowa
- Radiation Oncology Branch
- Tufts University School of Medicine
- University of Massachusetts Memorial Medical Center
- Barbara Ann Karmanos Cancer Institute
- University of Minnesota Cancer Center
- University of Mississippi Medical Center
- Ellis Fischel Cancer Center
- Washington University School of Medicine
- Cooper Hospital/University Medical Center
- Cancer Center of Albany Medical Center
- University of Rochester Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- Comprehensive Cancer Center at Wake Forest University
- Barrett Cancer Center, The University Hospital
- Ireland Cancer Center
- Arthur G. James Cancer Hospital - Ohio State University
- University of Oklahoma College of Medicine
- Abington Memorial Hospital
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Brookview Research, Inc.
- Simmons Cancer Center - Dallas
- University of Texas - MD Anderson Cancer Center
- Cancer Center at the University of Virginia
- Fred Hutchinson Cancer Research Center
- Tacoma General Hospital
- Tom Baker Cancer Center - Calgary
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005031
First Posted
April 6, 2000
Last Updated
May 24, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00005031
Brief Title
Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
Official Title
A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
irofulven
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell J. Schilder, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Radiation Oncology Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Hospital/University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Barrett Cancer Center, The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
15122083
Citation
Schilder RJ, Blessing JA, Pearl ML, Rose PG. Evaluation of irofulven (MGI-114) in the treatment of recurrent or persistent endometrial carcinoma: A phase II study of the Gynecologic Oncology Group. Invest New Drugs. 2004 Aug;22(3):343-9. doi: 10.1023/B:DRUG.0000026262.77502.31.
Results Reference
result
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Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
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