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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Peter M. Glassman, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000066281

NCT ID:

NCT00003328

Start Date:

December 1997

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • Head and Neck Neoplasms

Name

Location

Simmons Cancer Center - DallasDallas, Texas  75235-9154
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Health Advance InstitutePeoria, Illinois  61655-1466