Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Porfiromycin
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

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