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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


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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Angeles A. Secord, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000371712

NCT ID:

NCT00086892

Start Date:

June 2004

Completion Date:

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

Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
MBCCOP - Hawaii Honolulu, Hawaii  96813
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Women's Cancer Center - Los Gatos Los Gatos, California  95032
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Evanston Evanston, Illinois  60201
Hinsdale, Illinois  60521
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force Base Keesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Gynecologic Oncology Network Greenville, North Carolina  27858
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology Associates Knoxville, Tennessee  37917
CCOP - Scott and White Hospital Temple, Texas  76508
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus Burlington, Vermont  05401
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tufts - New England Medical Center Boston, Massachusetts  02111
SUNY Downstate Medical Center Brooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
Fox Chase-Temple Cancer Center Philadelphia, Pennsylvania  19111-2442
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Yale Comprehensive Cancer Center at Yale University School of Medicine New Haven, Connecticut  06520-8064
University of Virginia Cancer Center Charlottesville, Virginia  22908
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees Camden, New Jersey  08103
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612