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

Radiation Fibrosis Clinical Trial

Official title:

A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020631
• Other study ID #: CDR0000068675
• Secondary ID: NCI-01-C-0143
• Status: Completed
• Phase: N/A
• First received: July 11, 2001
• Last updated: June 17, 2013
• Start date: October 2001
• Est. completion date: October 2007

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00014924

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fibrosis
• Radiation Fibrosis
• Radiation Pneumonitis

Intervention

Drug:
• pirfenidone

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,