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

NCT ID: NCT00020631

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2007-10-31

Brief Summary

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.

Detailed 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.

Conditions

Radiation Fibrosis

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

pirfenidone

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Kevin Camphausen, MD

Role: PRINCIPAL_INVESTIGATOR

NCI - Radiation Oncology Branch; ROB

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-01-C-0143

Identifier Type: -

Identifier Source: secondary_id

CDR0000068675

Identifier Type: -

Identifier Source: org_study_id

NCT00014924

Identifier Type: -

Identifier Source: nct_alias