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

Alternate Title

Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Completed 18 and over NCI NCI-01-C-0143 NCT00014924

Objectives

1. Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.

Entry Criteria

Disease Characteristics:

• Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities)
  • At least moderate impairment in at least 1 of the following principal functional abilities:
    • Range of motion
    • Strength
    • Edema
    • Swallowing



• Prior radiation for cancer received more than 6 months ago



• No evidence of recurrent or metastatic cancer



• No history of collagen vascular disease



• No positive antinuclear antibody

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent anticancer immunotherapy

Chemotherapy:

• No concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics
• No concurrent anticancer radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent anticancer investigational agents
• Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Hepatitis B and C negative

Renal:

• Not specified

Other:

• HIV negative
• No evidence of second primary cancer
• No life-threatening situation requiring rehabilitation intervention
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 10-25 patients will be accrued for this study within 1 year.

Outline

Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Kevin Camphausen, MD, Principal investigator		Ph: 301-496-5457 Email: camphauk@mail.nih.gov

Registry Information
Official Title		A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
Trial Start Date		2001-10-16
Registered in ClinicalTrials.gov		NCT00014924
Date Submitted to PDQ		2001-04-23
Information Last Verified		2004-04-05