Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Pharmaceutical / Industry BOEH-PORF-96-001 BOEH-BI-1164.1, COVANCE-1403, VION-PORF-96-001, NCI-V98-1416, NCT00003328

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.

Entry Criteria

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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Boehringer Ingelheim Pharmaceuticals, Incorporated - Ridgefield

Peter M. Glassman, MD, PhD, Protocol chair		Ph: 203-798-4776; 800-243-0127 Email: pglassma@rdg.boehringer-ingelheim.com

Registry Information
Official Title		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
Trial Start Date		1997-12-01
Registered in ClinicalTrials.gov		NCT00003328
Date Submitted to PDQ		1998-05-12
Information Last Verified		2007-05-21