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Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

Phase 2
Not Enrolling
Cervical Cancer

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Trial Information

Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

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

Inclusion 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

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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

June 2004

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms



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University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Tufts University School of Medicine Boston, Massachusetts  02111
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Evanston Evanston, Illinois  60201
CCOP - Scott and White Hospital Temple, Texas  76508
North Shore University Hospital Manhasset, New York  11030
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
CCOP - Sooner State Tulsa, Oklahoma  74136
Medicine Branch Bethesda, Maryland  20892
Radiation Oncology Branch Bethesda, Maryland  20892
Ellis Fischel Cancer Center Columbia, Missouri  65203