Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
NCT ID: NCT00071929
Last Updated: 2013-06-24
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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COMPLETED
PHASE2
INTERVENTIONAL
1999-11-30
2007-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
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Detailed Description
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* Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy.
* Determine the nature and degree of toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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oxaliplatin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2 if received 1 prior therapy regimen
* GOG 0-1 if received 2 prior therapy regimens
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Neurologic
* No sensory or motor neuropathy greater than grade 1
* No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergy to platinum compounds or antiemetics
* No active infection requiring antibiotics
* No other uncontrolled illness
* No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 14 days since prior pegfilgrastim
* At least 24 hours since other prior growth factors
* At least 3 weeks since prior biologic or immunologic therapy
* No concurrent growth factors during first course of study therapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* No more than 1 prior cytotoxic chemotherapy regimen, either single or combination cytotoxic drug therapy
* No prior oxaliplatin
Endocrine therapy
* At least 1 week since prior hormonal therapy directed at tumor
* Concurrent hormone replacement therapy allowed
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Surgery
* Recovered from any recent surgery
Other
* At least 3 weeks since prior therapy for endometrial cancer
* No other concurrent investigational agents
* No prior anticancer therapy that would preclude study participation
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Paula M. Fracasso, MD, PhD
Role: STUDY_CHAIR
Washington University Siteman Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
New Britain General Hospital
New Britain, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Countries
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References
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Fracasso PM, Blessing JA, Molpus KL, Adler LM, Sorosky JI, Rose PG. Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):523-6. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19.
Other Identifiers
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GOG-0129K
Identifier Type: -
Identifier Source: secondary_id
CDR0000068235
Identifier Type: -
Identifier Source: org_study_id
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