NCT00100789

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Detailed description

OBJECTIVES: * Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel. * Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
DRUG	paclitaxel	150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-01-07
• Last updated: 2012-10-01
• Results posted: 2012-10-01

Locations

123 sites across 1 country: United States