NCT00499031

Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Squamous Cell Carcinoma
• Recurrent Cervical Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab	Given IV

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-01-01
• First posted: 2007-07-11
• Last updated: 2015-01-13
• Results posted: 2014-06-24

Locations

22 sites across 1 country: United States