NCT00003908

S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Evaluation of the Combination of Docetaxel (Taxotere)/ Carboplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 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 docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.

Detailed description

OBJECTIVES: I. Assess the survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck receiving docetaxel and carboplatin. II. Assess time to treatment failure and response rate (unconfirmed and confirmed complete and partial response) in this patient population. III. Evaluate the toxicities of this regimen in this patient population. OUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death. PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	docetaxel

Timeline

• Start date: 1999-11-01
• Primary completion: 2004-06-01
• Completion: 2007-01-01
• First posted: 2004-05-21
• Last updated: 2013-04-18

Locations

85 sites across 1 country: United States