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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00499031 |
Purpose
RATIONALE: 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.
PURPOSE: This phase II trial is studying cetuximab to see how well it works in treating patients with persistent or recurrent cervical cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Biological: cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Patients must have persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy)
All patients must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
Patients must have at least one target lesion to be used to assess response on this protocol
Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
Patients must not be eligible for a higher priority GOG protocol, if one exists
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Patients with a history of other invasive malignancies, with the exception of nonmelanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last five years
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Recovery from effects of recent surgery, radiotherapy, or chemotherapy
Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent cervical disease according to the following definition:
Exclusion criteria:
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervical cancer within the last five years are excluded
Patients who have received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of cervical cancer within the last five years are excluded
Contacts and Locations
Show 35 Study Locations| Study Chair: | Alessandro Santin, MD | University of Arkansas |
More Information
| ClinicalTrials.gov Identifier: | NCT00499031 History of Changes |
| Other Study ID Numbers: | CDR0000554455, GOG-0227E, BMS-CA225-275 |
| Study First Received: | July 10, 2007 |
| Last Updated: | August 4, 2009 |
| Health Authority: | United States: Federal Government |
|
cervical squamous cell carcinoma recurrent cervical cancer |
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |