NCT00021333

Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer

Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy. PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.

Detailed description

OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.

Conditions

• Head and Neck Cancer
• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cisplatin
DRUG	paclitaxel
RADIATION	radiation therapy

Timeline

• Start date: 1999-09-01
• Primary completion: 2006-04-01
• Completion: 2008-05-01
• First posted: 2004-01-14
• Last updated: 2013-04-17

Locations

18 sites across 1 country: United States