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

National Cancer Institute (NCI)

Status: Completed

Conditions: Radiation Fibrosis

Treatments: Drug: pirfenidone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00020631

CDR0000068675

NCI-01-C-0143

Details and patient eligibility

About

RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.

PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

Full description

OBJECTIVES:

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

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.

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

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