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| Sponsor: | Minneapolis Veterans Affairs Medical Center |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | Minneapolis Veterans Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT00557206 |
Purpose
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Head and Neck Neoplasms |
Drug: Oxaliplatin and Docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck |
| Enrollment: | 35 |
| Study Start Date: | April 2005 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
This is a single arm trial.
|
Drug: Oxaliplatin and Docetaxel
Chemotherapy Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days. |
Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection
Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.
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, Minnesota | |
| VA Medical Center | |
| Minneapolis, Minnesota, United States, 55417 | |
| Principal Investigator: | Balkrishna Jahagirdar, MD | Minneapolis Veterans Affairs Medical Center |
| Principal Investigator: | Vicki A Morrison, MD | Minneapolis Veterans Affairs Medical Center |
More Information
| Responsible Party: | Balkrishna Jahagirdar, MD; Principal Investigator, VA CORNET (VA Clinical Oncology Research Network) |
| ClinicalTrials.gov Identifier: | NCT00557206 History of Changes |
| Other Study ID Numbers: | OX-04-033, VA-CORNET |
| Study First Received: | November 9, 2007 |
| Last Updated: | August 10, 2011 |
| Health Authority: | United States: Federal Government |
|
Recurrent Disease Metastatic Disease Squamous Cell Carcinoma Multicenter Phase II |
|
Neoplasms Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell |
Neoplasms by Site Oxaliplatin Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |