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NCT01696955 · ClinicalTrials.gov registry record · Phase 2
Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery
A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT01696955: Completed Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01696955 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 81 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696955, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Tivantinib
Study Locations (20)
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- Decatur Memorial Hospital - Decatur
- NorthShore University HealthSystem-Evanston Hospital - Evanston
- Ingalls Memorial Hospital - Harvey
- Illinois CancerCare-Peoria - Peoria
- Southern Illinois University School of Medicine - Springfield
California
- City of Hope Comprehensive Cancer Center - Duarte
- USC / Norris Comprehensive Cancer Center - Los Angeles
- University of California Davis Comprehensive Cancer Center - Sacramento
- City of Hope South Pasadena - South Pasadena
Indiana
- Fort Wayne Medical Oncology and Hematology Inc-Parkview - Fort Wayne
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- Wayne State University/Karmanos Cancer Institute - Detroit
Minnesota
- Mayo Clinic - Rochester
- Metro Minnesota Community Oncology Research Consortium - Saint Louis Park
Arizona
- Mayo Clinic in Arizona - Scottsdale
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2017-05-05 |
| Phase | Phase 2 |
What the finished NCT01696955 record still lists
NCT01696955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (31% lower).
The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT01696955 names 20 study sites across 8 states, led by Illinois, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT01696955 about?
NCT01696955 is a clinical study titled "Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery". This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, ma...
What is the current status of trial NCT01696955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2012-08-20. Estimated completion is 2017-05-05.
What conditions does trial NCT01696955 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma.
What interventions are being tested in trial NCT01696955?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01696955?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01696955 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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