Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer
Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
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 oxaliplatin in treating patients who have recurrent or refractory cervical cancer.
연구 개요
상세 설명
OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory squamous cell carcinoma of the cervix who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, 미국, 85006-2726
- CCOP - Greater Phoenix
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California
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Los Angeles, California, 미국, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, 미국, 92868
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, 미국, 94304
- Women's Cancer Center
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Colorado
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Denver, Colorado, 미국, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, 미국, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, 미국, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa, Florida, 미국, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, 미국, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, 미국, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, 미국, 60637
- University of Chicago Cancer Research Center
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Decatur, Illinois, 미국, 62526
- CCOP - Central Illinois
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Evanston, Illinois, 미국, 60201
- CCOP - Evanston
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Indiana
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Indianapolis, Indiana, 미국, 46202-5265
- Indiana University Cancer Center
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Iowa
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Des Moines, Iowa, 미국, 50309-1016
- CCOP - Iowa Oncology Research Association
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, 미국, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Oncology Center
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Bethesda, Maryland, 미국, 20892
- Radiation Oncology Branch
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Bethesda, Maryland, 미국, 20892
- Medicine Branch
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- Tufts University School of Medicine
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Worcester, Massachusetts, 미국, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, 미국, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota Cancer Center
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, 미국, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center
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Kansas City, Missouri, 미국, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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Springfield, Missouri, 미국, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, 미국, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, 미국, 68131
- CCOP - Missouri Valley Cancer Consortium
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Nevada
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Las Vegas, Nevada, 미국, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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Camden, New Jersey, 미국, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, 미국, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, 미국, 11203
- State University of New York Health Science Center at Brooklyn
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Manhasset, New York, 미국, 11030
- North Shore University Hospital
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New York, New York, 미국, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, 미국, 14642
- University of Rochester Cancer Center
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Stony Brook, New York, 미국, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, 미국, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Cancer Center
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Cleveland, Ohio, 미국, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, 미국, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73190
- University of Oklahoma College of Medicine
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Tulsa, Oklahoma, 미국, 74136
- CCOP - Sooner State
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Oregon
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Portland, Oregon, 미국, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Abington, Pennsylvania, 미국, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, 미국, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, 미국, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Wynnewood, Pennsylvania, 미국, 19096
- CCOP - MainLine Health
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South Carolina
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Charleston, South Carolina, 미국, 29425-0721
- Medical University of South Carolina
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Spartanburg, South Carolina, 미국, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, 미국, 38117
- CCOP - Baptist Cancer Institute
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Nashville, Tennessee, 미국, 37203
- Brookview Research, Inc.
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Texas
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Dallas, Texas, 미국, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, 미국, 77030
- University of Texas - MD Anderson Cancer Center
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Temple, Texas, 미국, 76508
- CCOP - Scott and White Hospital
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Virginia
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Charlottesville, Virginia, 미국, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, 미국, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, 미국, 98405
- Tacoma General Hospital
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
- Tom Baker Cancer Center - Calgary
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapeutic measures and considered incurable Bidimensionally measurable disease Must not be eligible for a higher priority GOG protocol No known brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine normal Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No evidence of preexisting peripheral sensory neuropathy greater than CTC grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior oxaliplatin No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered Other: At least 3 weeks since prior anticancer therapy and recovered No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .