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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. completion date
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


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

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