A Phase II Evaluation of Cetuximab (Erbitux®, C225, NSC# 714692) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix
OBJECTIVES:
Primary
- To assess the activity of cetuximab for patients with persistent or recurrent carcinoma
of the cervix.
- To determine the frequency of patients who survive progression-free for at least 6
months after initiating therapy or have objective tumor response.
Secondary
- To characterize the distribution of progression-free survival and overall survival.
- To determine the effect of cetuximab on the duration of objective response in
persistent or recurrent carcinoma of the cervix.
- To determine the nature and degree of toxicity of cetuximab as assessed by CTCAE v3.0
in this cohort of patients.
OUTLINE: Patients receive cetuximab IV over 120 minutes on day 1. Courses repeat once weekly
in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed (with physical exams and histories)
every three months for the first two years and then every six months for the next three
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
No
Alessandro Santin, MD
Study Chair
University of Arkansas
United States: Federal Government
CDR0000554455
NCT00499031
June 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Colorado Gynecologic Oncology Group, PC | Aurora, Colorado 80010 |
Black Hills Obstetrics & Gynecology LLP | Rapid City, South Dakota 57701 |