A Phase III Double-Blind, Randomised, Placebo-Controlled Study of Porfiromycin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Cancer
- NCT00003328
- PHASE3
- INTERVENTIONAL
Last updated: 2010-05-21
Purpose of Trial
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.
This study is for people with
Head and Neck Cancer
Interventions being studied
porfiromycin
radiation therapy
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV squamous cell (epidermoid) carcinoma of head and neck limited to the oral cavity, oropharynx, hypopharynx, or larynx No distant metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 No known bleeding disorder Hepatic: Bilirubin no greater than 2 times normal No end stage liver disease PT and PTT no greater than 1.5 times normal Renal: Creatinine less than 2 times normal No end stage renal disease Cardiovascular: No unstable angina Pulmonary: No severe oxygen dependent chronic obstructive pulmonary disease Other: No other malignancy known to be active within the past 5 years except basal or squamous cell skin cancer outside the planned radiation portals or carcinoma in situ of the cervix No other life threatening illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for head and neck cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for head and neck cancer Surgery: No prior surgery (other than biopsy) for head and neck cancer
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
4 Locations
Washington
Veterans Affairs Medical Center - Washington, DC
District of Columbia, 20422, United States
Peoria
Health Advance Institute
Illinois, 61655-1466, United States
Dallas
Simmons Cancer Center - Dallas
Texas, 75235-9154, United States
Milwaukee
Medical College of Wisconsin
Wisconsin, 53226, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov
