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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020631
First received: July 11, 2001
Last updated: June 17, 2013
Last verified: April 2004
  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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020631

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00020631     History of Changes
Obsolete Identifiers: NCT00014924
Other Study ID Numbers: CDR0000068675, NCI-01-C-0143
Study First Received: July 11, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014