Spots Global Cancer Trial Database for Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer
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Trial Identification
Brief Title: Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title: 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
Study ID: NCT00499031
Interventions
Study Description
Brief Summary: This phase II trial is studying cetuximab to see how well it works in treating patients with persistent or recurrent cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the activity of cetuximab for patients with persistent or recurrent carcinoma of the cervix. II. To determine the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response. SECONDARY OBJECTIVES: I. To characterize the distribution of progression-free survival and overall survival. II. To determine the effect of cetuximab on the duration of objective response in persistent or recurrent carcinoma of the cervix. III. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Colorado Gynecologic Oncology Group, Aurora, Colorado, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Saint Vincent Hospital and Health Services, Indianapolis, Indiana, United States
Singing River Hospital, Pascagoula, Mississippi, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Island Gynecologic Oncology, Brightwaters, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Akron General Medical Center, Akron, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Cancer Care Associates-Midtown, Tulsa, Oklahoma, United States
Tulsa Cancer Institute, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
AnMed Health Hospital, Anderson, South Carolina, United States
M D Anderson Cancer Center, Houston, Texas, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Alessandro Santin
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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