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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients

NCT02183246

Head and Neck Neoplasms

TERMINATED PHASE3

Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

NCT00002507

Carcinoma of Unknown Primary Head and Neck Cancer

COMPLETED PHASE3

High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer

NCT00002555

Head and Neck Cancer

COMPLETED PHASE3

PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck

NCT00011778

Squamous Cell Carcinoma

COMPLETED PHASE1

Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer

NCT00006360

Head and Neck Cancer Radiation Toxicity

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

porfiromycin

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No