Radiation Therapy Plus Porfiromycin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 3

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00003328
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy followed by porfiromycin is more effective than radiation therapy alone in treating patients with head and neck cancer.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of radiation therapy followed by porfiromycin in treating patients with stage III or stage IV head and neck cancer.

Detailed Description

OBJECTIVES: I. Determine the time to tumor progression in patients with stage III or IV (without distant metastases) head and neck cancer treated with porfiromycin as adjuvant therapy to radiotherapy. II. Determine percentage of patients with locoregional tumor recurrence up to 2 years posttreatment. III. Determine response rate, disease free survival time, and overall survival time in these patients. IV. Evaluate the safety and tolerance of porfiromycin in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to primary tumor site (oral vs pharynx vs larynx) and disease stage (both T and N stage: T1-2 vs T3-4 and N0 vs N1-2 vs N3). All patients are randomized to receive either porfiromycin (arm I) or placebo (arm II) as adjuvant therapy to radiation therapy. Both arms follow the same treatment schedule. Daily radiation therapy commences on day 1. Patients receive porfiromycin or placebo by intravenous infusion over 30-60 minutes on day 5 and then on day 46 or 47. Porfiromycin or placebo is administered 30 minutes to 2 hours following radiation therapy. All patients with N3 neck disease (metastases in a lymph node more than 6 cm in greatest dimension) undergo a planned neck dissection following external beam radiation at 4 to 12 weeks following therapy. This surgery is not needed for patients with N3 neck disease who do not have residual disease following radiotherapy. Patients are followed at 4 weeks, then every 2 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 550-600 patients will be accrued for this study within 3 years.

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-15
• Study First Posted: 2004-07-16
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-20
• Last Update Posted: 2010-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Veterans Affairs Medical Center - Washington, DC; 🇺🇸 Washington, District of Columbia, United States

Health Advance Institute; 🇺🇸 Peoria, Illinois, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Simmons Cancer Center - Dallas; 🇺🇸 Dallas, Texas, United States