Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

NCT00086892 | Completed Phase 2 DMC

• 3 other identifiers: GOG-0146PBMS-CA225-019CDR0000371712
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 76

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Interventions

cetuximab BIOLOGICAL

carboplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan * Target lesion not within previously irradiated field * Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound * Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel * Platinum-sensitive disease * Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen * If there is another concurrently active GOG-0146 series protocol (non-platinum-based therapy), must have had a treatment-free interval of more than 12 months unless ineligible for the other protocol\* NOTE: \*Applies whether or not both protocols are available at the same participating center * Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking * Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No uncontrolled hypertension * No unstable angina * No congestive heart failure * No uncontrolled arrhythmias within the past 6 months * No other significant cardiac disease Neurologic * No uncontrolled seizure disorder * No active neurological disease * No neuropathy \> grade 1 Other * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No active infection requiring antibiotics * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior anti-epidermal growth factor receptor (EGFR) antibody therapy * No prior chimerized or murine monoclonal antibody therapy * At least 3 weeks since prior biologic or immunologic therapy for the malignancy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens Endocrine therapy * At least 1 week since prior hormonal therapy for the malignancy * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No prior radiotherapy to \> 25% of bone marrow-bearing areas Surgery * More than 30 days since prior major surgery and recovered * Diagnostic biopsy not considered major surgery Other * At least 3 weeks since other prior therapy for the malignancy * No prior tyrosine kinase inhibitors that target the EGFR pathway * No prior cancer treatment that would preclude study treatment * No other concurrent investigational agents

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
• Bristol-Myers Squibb: collaborator

Study Sites (76)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1740, United States

Location

Women's Cancer Center - Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, 06520-8028, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3824, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62794-9640, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Unknown Facility

Hinsdale, Illinois, 60521, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01605-2982, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905-0001, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler Air Force Base

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

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

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

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Camden, New Jersey, 08103-1489, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, 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

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11790-7775, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7570, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Gynecologic Oncology Network

Greenville, North Carolina, 27858, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0520, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44124, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73104, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Southeast Gynecologic Oncology Associates

Knoxville, Tennessee, 37917, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-2516, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9032, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

Burlington, Vermont, 05401, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6188, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Australia New Zealand Gynaecological Oncology Trials Group

Camperdown, New South Wales, 1450, Australia

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Kagoshima City Hospital

Kagoshima, 892-8580, Japan

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

• Secord AA, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS; Gynecologic Oncology Group. Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Mar;108(3):493-9. doi: 10.1016/j.ygyno.2007.11.029. Epub 2008 Jan 14.

  PMID: 18191993 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Cetuximab; Carboplatin

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Angeles A. Secord, MD

  Duke Cancer Institute

  STUDY CHAIR

• Deborah K. Armstrong, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Nita Maihle, PhD

  Yale University

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: June 1, 2004
• Primary Completion: April 1, 2006
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

CA (1); JP (1); NO (1); US (72); AU (1)