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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086892
• Other study ID #: GOG-0146P
• Secondary ID: BMS-CA225-019CDR
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2004
• Last updated: February 12, 2014
• Start date: June 2004

Study information

• Verified date: February 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• cetuximab

Drug:
• carboplatin

Locations

Country	Name	City	State
Australia	Australia New Zealand Gynaecological Oncology Trials Group	Camperdown	New South Wales
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Japan	Kagoshima City Hospital	Kagoshima City
Norway	Norwegian Radium Hospital	Oslo
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus	Burlington	Vermont
United States	Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Evanston	Evanston	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Gynecologic Oncology Network	Greenville	North Carolina
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler Air Force Base	Keesler AFB	Mississippi
United States	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Women's Cancer Center - Los Gatos	Los Gatos	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Yale Comprehensive Cancer Center at Yale University School of Medicine	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase-Temple Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	Bristol-Myers Squibb, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  Norway, 

References & 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 — View Citation