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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003328
First received: November 1, 1999
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: porfiromycin
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 600
Study Start Date: December 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003328

Locations
United States, District of Columbia
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
United States, Illinois
Health Advance Institute
Peoria, Illinois, United States, 61655-1466
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Peter M. Glassman, MD, PhD Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003328     History of Changes
Other Study ID Numbers: CDR0000066281, BOEH-PORF-96-001, BOEH-BI-1164.1, COVANCE-1403, VION-PORF-96-001, NCI-V98-1416
Study First Received: November 1, 1999
Last Updated: May 20, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Porfiromycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014