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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00020631
First Posted: January 27, 2003
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Radiation Fibrosis Drug: pirfenidone

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
Study Completion Date: October 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020631


Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kevin Camphausen, MD NCI - Radiation Oncology Branch; ROB
  More Information

ClinicalTrials.gov Identifier: NCT00020631     History of Changes
Obsolete Identifiers: NCT00014924
Other Study ID Numbers: CDR0000068675
NCI-01-C-0143
First Submitted: July 11, 2001
First Posted: January 27, 2003
Last Update Posted: June 19, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
radiation fibrosis

Additional relevant MeSH terms:
Fibrosis
Radiation Pneumonitis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Radiation Injuries
Wounds and Injuries
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents