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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer



Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

For Condition: cervical squamous cell carcinoma,recurrent cervical cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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) --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulaFracasso,  Study Chair,  Gynecologic Oncology Group

Cleveland Clinic Cancer Center
Cleveland,  Ohio,  44195
United States
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612
United States
 

CCOP - Baptist Cancer Institute
Memphis,  Tennessee,  38117
United States
 

University of Oklahoma College of Medicine
Oklahoma City,  Oklahoma,  73190
United States
 

Medicine Branch
Bethesda,  Maryland,  20892
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

USC/Norris Comprehensive Cancer Center
Los Angeles,  California,  90033-0800
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia,  Pennsylvania,  19107
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

State University of New York Health Sciences Center - Stony Brook
Stony Brook,  New York,  11790-7775
United States
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

University of Massachusetts Memorial Medical Center
Worcester,  Massachusetts,  01655
United States
 

University of Iowa Hospitals and Clinics
Iowa City,  Iowa,  52242
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

Tom Baker Cancer Center - Calgary
Calgary,  Alberta,  T2N 4N2
Canada
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5265
United States
 

CCOP - Sooner State
Tulsa,  Oklahoma,  74136
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 

Johns Hopkins Oncology Center
Baltimore,  Maryland,  21287
United States
 

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

Cancer Center, University of Virginia HSC
Charlottesville,  Virginia,  22908
United States
 

Washington University School of Medicine
St. Louis,  Missouri,  63110
United States
 

Cooper Hospital/University Medical Center
Camden,  New Jersey,  08103
United States
 

Radiation Oncology Branch
Bethesda,  Maryland,  20892
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104
United States
 

University of Washington Medical Center
Seattle,  Washington,  98195-6043
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

CCOP - Columbia River Program
Portland,  Oregon,  97213
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68131
United States
 

Tacoma General Hospital
Tacoma,  Washington,  98405
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

Rush-Presbyterian-St. Luke's Medical Center
Chicago,  Illinois,  60612
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C.,  District of Columbia,  20007
United States
 

Ellis Fischel Cancer Center
Columbia,  Missouri,  65203
United States
 

Cancer Center of Albany Medical Center
Albany,  New York,  12208
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

University of Rochester Cancer Center
Rochester,  New York,  14642
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210
United States
 

Abington Memorial Hospital
Abington,  Pennsylvania,  19001
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

University of Alabama Comprehensive Cancer Center
Birmingham,  Alabama,  35294
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80262
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

Women's Cancer Center
Palo Alto,  California,  94304
United States
 

Tufts University School of Medicine
Boston,  Massachusetts,  02111
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45219
United States
 

Milton S. Hershey Medical Center
Hershey,  Pennsylvania,  17033
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 

Keesler Medical Center - Keesler AFB
Keesler AFB,  Mississippi,  39534-2576
United States
 

MBCCOP - Hawaii
Honolulu,  Hawaii,  96813
United States
 

Brookview Research, Inc.
Nashville,  Tennessee,  37203
United States
 

State University of New York Health Science Center at Brooklyn
Brooklyn,  New York,  11203
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067852;  GOG-127P
Study Start Date: February 2000
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005837

Other Recurrent Cervical Cancer Studies:
1. SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

2. DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix

3. Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix

4. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

5. Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

Related Studies:

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Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

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