Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer
|ClinicalTrials.gov Identifier: NCT00499031|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : June 24, 2014
Last Update Posted : January 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma||Biological: Cetuximab||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2007|
|Actual Primary Completion Date :||January 2012|
Experimental: Treatment (cetuximab)
Patients receive cetuximab IV over 120 minutes on day 1.
- Progression-free Survival Greater Than 6 Months [ Time Frame: At 6 months ]
- Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: every other cycle for the first 6 months; then every 3 months x 2; then every 6 months ]
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Stable Disease is any condition not meeting the above criteria.
Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
- Duration of Progression-free Survival [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ]
- Duration of Objective Response Rate [ Time Frame: Up to 5 years ]
- Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ]
- Duration of Overall Survival [ Time Frame: From study entry to death or the date of last contact, up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499031
Show 22 Study Locations
|Principal Investigator:||Alessandro Santin||Gynecologic Oncology Group|