NCT00002922

Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

Phase II Evaluation of Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or metastatic head and neck cancer.

Detailed description

OBJECTIVES: I. Evaluate the response rate and toxic effects of paclitaxel by 96 hour continuous infusion in chemotherapy naive and chemotherapy exposed patients with recurrent or metastatic squamous cell carcinoma of the head and neck. OUTLINE: Patients receive paclitaxel as a 96 hour continuous IV infusion. Courses repeat every 3 weeks for a maximum of 12 courses. Patients with disease progression after 2 courses or with unacceptable toxicity at any time are removed from study. PROJECTED ACCRUAL: Approximately 109 patients will be accrued for this study over 4 years.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel

Timeline

• Start date: 1997-02-21
• Primary completion: 2001-09-01
• First posted: 2004-07-07
• Last updated: 2023-06-18

Locations

24 sites across 2 countries: United States, South Africa