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
5 other identifiers
interventional
38
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedResults Posted
Study results publicly available
June 24, 2014
CompletedJanuary 13, 2015
December 1, 2014
4.6 years
July 10, 2007
May 22, 2014
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival Greater Than 6 Months
At 6 months
Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
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.
every other cycle for the first 6 months; then every 3 months x 2; then every 6 months
Secondary Outcomes (4)
Duration of Progression-free Survival
From study entry until disease progression, death or date of last contact, up to 5 years
Duration of Objective Response Rate
Up to 5 years
Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Up to 5 years
Duration of Overall Survival
From study entry to death or the date of last contact, up to 5 years
Study Arms (1)
Treatment (cetuximab)
EXPERIMENTALPatients receive cetuximab IV over 120 minutes on day 1.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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)
- Histologic documentation of the original primary tumor is required via the pathology report
- 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)
- Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, and MRI, OR ≥ 10 mm when measured by spiral CT scan
- Patients must have at least one target lesion to be used to assess response on this protocol
- Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
- Chemotherapy administered in conjunction with primary radiation as a radiosensitizer is not counted as a systemic chemotherapy regimen
- Patients must not be eligible for a higher priority GOG protocol, if one exists
- In general, this would refer to any active GOG phase III protocol for the same patient population
You may not qualify if:
- Patients with craniospinal metastases
- Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2 or patients who have received two prior regimens must have a GOG performance status of 0 or 1
- Patients should be free of active infection requiring antibiotics
- Platelet count ≥ 100,000/μl
- ANC ≥ 1,500/μl
- Creatinine ≤ 1.5 x institutional upper limit normal (ULN)
- Bilirubin ≤ 1.5 x ULN
- SGOT and alkaline phosphatase ≤ 2.5 x ULN
- Neuropathy (sensory and motor) ≤ CTCAE v3.0 grade 1
- Calcium \< 11.0 mg/dL
- Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least two months following completion of protocol therapy
- 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
- Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have a significant history of cardiac disease (i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias) within 6 months of registration
- Patients who have an uncontrolled seizure disorder or active neurological disease
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (22)
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Island Gynecologic Oncology
Brightwaters, New York, 11718, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melissa Leventhal
- Organization
- NRG Oncology Statisics and Data Management Center, Buffalo Office
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Santin
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 11, 2007
Study Start
June 1, 2007
Primary Completion
January 1, 2012
Last Updated
January 13, 2015
Results First Posted
June 24, 2014
Record last verified: 2014-12