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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Information provided by: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00599131 |
Purpose
The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy).
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of Larynx |
Drug: Cisplatin Drug: Cetuximab Drug: 5-Fluorouracil Drug: Docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Organ Preservation Trial Using Cetuximab and Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to One Cycle of Induction Chemotherapy With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2010 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
In this study one cycle of chemotherapy will be administered and then those subjects who respond well to that cycle will be started on radiation therapy along with chemotherapy and those that don't respond well to the initial cycle of chemotherapy, will undergo a total laryngectomy (surgery to remove the voice box) followed by radiation therapy. The initial cycle of chemotherapy consists of the drugs Taxotere, Cisplatin, and 5-Fluorouracil (this combination is known as TPF). Then on Day 20 of the study, the subjects will be administered another chemotherapy agent called cetuximab (a.k.a. C-225). It will then be determined if the patient's response to the chemotherapy was favorable by examining the patient's tumor with an endoscopy. If the response is determined to be good, then the patient will continue with a chemotherapy regimen with the addition of radiation therapy combination. If the patient's response to the chemotherapy is determined to be less than favorable, then the patient will be advised to undergo salvage surgery (a.k.a. laryngectomy) to remove their voice box and then undergo radiation therapy treatment. Additionally, tumor tissue samples and blood will be studied to see if there are special molecular markers that help predict when a tumor will respond to chemotherapy and radiation treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0848 | |
| Principal Investigator: | Francis P. Worden, M.D. | University of Michigan |
More Information
| Responsible Party: | University of Michigan ( Francis P.Worden, M.D., Clinical Assistant Professor ) |
| Study ID Numbers: | UMCC 2007.029 |
| Study First Received: | December 12, 2007 |
| Last Updated: | May 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00599131 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cancer of Larynx |
|
Antimetabolites Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cetuximab Laryngeal Neoplasms Immunosuppressive Agents |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Therapeutic Uses Head and Neck Neoplasms Fluorouracil Laryngeal Diseases |