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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bayer |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00494182 |
Primary Objective:
1. To evaluate the progression free survival of the combination of sorafenib (BAY 43-9006), carboplatin, and paclitaxel in patients with recurrent or metastatic SCCHN.
Secondary Objective:
1. Response rate, toxicity, safety profile, exploratory biomarker data, and overall survival.
Condition | Intervention | Phase |
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Head and Neck Cancer Squamous Cell Carcinoma |
Drug: Sorafenib Drug: Carboplatin Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer |
Estimated Enrollment: | 43 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sorafenib + Carboplatin + Paclitaxel
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Drug: Sorafenib
400 mg PO Twice Daily On Day 2-19
Drug: Carboplatin
6 AUC IV Over 30 Minutes On Day 1
Drug: Paclitaxel
200 mg/m^2 IV Over 3 Hours On Day 1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: George Blumenschein, MD | 713-792-6363 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: George Blumenschein, MD |
Principal Investigator: | George Blumenschein, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( George Blumenschein, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0940 |
Study First Received: | June 28, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00494182 |
Health Authority: | United States: Institutional Review Board |
Head and Neck Cancer Squamous Cell Carcinoma Sorafenib BAY 43-9006 |
Carboplatin Paclitaxel SCCHN |
Epidermoid carcinoma Paclitaxel Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell Carboplatin |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Sorafenib Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |