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


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

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
months.

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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067852

NCT ID:

NCT00005837

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Tufts University School of MedicineBoston, Massachusetts  02111
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Scott and White HospitalTemple, Texas  76508
North Shore University HospitalManhasset, New York  11030
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
CCOP - Sooner StateTulsa, Oklahoma  74136
Medicine BranchBethesda, Maryland  20892
Radiation Oncology BranchBethesda, Maryland  20892
Ellis Fischel Cancer CenterColumbia, Missouri  65203