Know Cancer

or
forgot password

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 InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Women's Cancer Center - Los GatosLos Gatos, California  95032
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - EvanstonEvanston, Illinois  60201
Hinsdale, Illinois  60521
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Gynecologic Oncology NetworkGreenville, North Carolina  27858
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
CCOP - Scott and White HospitalTemple, Texas  76508
Fletcher Allen Health Care - Medical Center Hospital of Vermont CampusBurlington, Vermont  05401
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tufts - New England Medical CenterBoston, Massachusetts  02111
SUNY Downstate Medical CenterBrooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612