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Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer


OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in
patients with recurrent or refractory, platinum resistant ovarian epithelial or primary
peritoneal carcinoma 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 recurrent or refractory ovarian
epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and
pleural effusions are not considered measurable disease Sonography acceptable provided
lesions are clearly defined on initial examination and bidimensionally measurable Must
have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or
another organoplatinum compound for management of primary disease Initial treatment may
include high dose therapy, consolidation, or extended therapy administered after surgical
or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent
or persistent disease, including retreatment with initial chemotherapy regimens Must be
considered platinum resistant or refractory Treatment free interval of less than 6 months
following platinum or progression during platinum based therapy No known brain metastases
Must not be eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least lower limit of normal 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 No unstable angina pectoris No cardiac arrhythmia Other: Not
pregnant or nursing Fertile patients must use effective contraception No active infection
requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater
than 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: At least 3 weeks since prior biologic therapy
At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs)
during first course of therapy At least 24 hours since prior CSFs during subsequent
courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more
than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second
regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and
recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at
malignant tumor Concurrent continuation of hormone replacement therapy allowed
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior
radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to
greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and
recovered Other: 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:

CDR0000067851

NCT ID:

NCT00005836

Start Date:

February 2000

Completion Date:

July 2004

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
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
Brookview Research, Inc. Winston-Salem, North Carolina  27103
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
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
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
CCOP - Greenville Greenville, South Carolina  29615
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
Medicine Branch Bethesda, Maryland  20892
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Radiation Oncology Branch Bethesda, Maryland  20892
Ellis Fischel Cancer Center Columbia, Missouri  65203