NCT00494182

Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Drugs used in chemotherapy, such as sorafenib, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the progression free survival of the combination of sorafenib (BAY 43-9006), carboplatin, and paclitaxel in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN). SECONDARY OBJECTIVES: I. Response rate, toxicity, safety profile, exploratory biomarker data, and overall survival. OUTLINE: Participants receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib orally (PO) twice daily (BID) on days 2-19. Treatment repeats every 21 days for up to 6 courses. Starting with course 7, participants receive sorafenib PO daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up between 21-35 days.

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Squamous Cell Carcinoma of the Hypopharynx
• Metastatic Squamous Cell Carcinoma of the Larynx
• Metastatic Squamous Cell Carcinoma of the Oral Cavity
• Metastatic Squamous Cell Carcinoma of the Oropharynx
• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Oral Cavity Squamous Cell Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Paclitaxel	Given IV
DRUG	Sorafenib	Given PO

Timeline

• Start date: 2007-04-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2007-06-29
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study