S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT ID: NCT00053833
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2003-04-30
2004-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Detailed Description
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* Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with irinotecan.
* Determine the progression-free and overall survival of patients treated with this drug.
* Evaluate the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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irinotecan
irinotecan
irinotecan
Interventions
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irinotecan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
* No mixed mullerian and borderline ovarian tumors
* Surgically staged as stage III or IV at initial diagnosis
* Must meet one of the following criteria for refractory/relapsed disease:
* Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy
* Had a best response of increasing disease during this front-line regimen
* Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen
* Unidimensionally measurable disease
* At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included)
* At least 1 cm by spiral CT scan
* Measurable disease must remain outside of radiotherapy field
* If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No myocardial infarction within the past 6 months
* No angina pectoris
* No uncontrolled congestive heart failure
* No uncontrolled cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except for the following:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer from which the patient is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 1 prior biological response modifier
* At least 28 days since prior biological response modifier and recovered
Chemotherapy
* See Disease Characteristics
* No prior topotecan or other topoisomerase I inhibitor
* One other additional prior chemotherapy regimen allowed
* At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered
Endocrine therapy
* Prior hormonal therapy allowed
* No concurrent hormonal therapy
Radiotherapy
* At least 28 days since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of bone marrow
* No concurrent palliative radiotherapy
Surgery
* At least 14 days since prior major surgery and recovered
Other
* At least 28 days since prior investigational drugs and recovered
* No other concurrent antitumor therapy
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Amy D. Tiersten, MD
Role: STUDY_CHAIR
NYU Langone Health
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center
Fresno, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at the University of Rochester Medical Center
Rochester, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Oregon Cancer Institute
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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S0025
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000269486
Identifier Type: -
Identifier Source: org_study_id