Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy

NCT00005836 | Completed Phase 2

• 2 other identifiers: CDR0000067851GOG-126K
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 74

Brief Summary

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 ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Interventions

oxaliplatin DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (74)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Women's Cancer Center

Palo Alto, California, 94304, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Central Illinois

Springfield, Illinois, 62526, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 10309-1016, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

Radiation Oncology Branch

Bethesda, Maryland, 20892, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-9832, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Brookview Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Baptist Cancer Institute

Memphis, Tennessee, 38117, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Cancer Center, University of Virginia HSC

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

NCIC-Clinical Trials Group

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Paula M. Fracasso, MD, PhD

  Washington University Siteman Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: April 29, 2003
• Study Start: February 1, 2000
• Study Completion: July 1, 2004
• Last Updated: June 21, 2013

Record last verified: 2003-03

Locations

US (73); CA (1)