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

This study has been completed.
Study NCT00020631.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
Official Title † A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
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.
Study Phase
Study Type † Interventional
Study Design † Supportive Care
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Cancer-Related Problem/Condition
Intervention † Drug: pirfenidone
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Completed
Enrollment †
Start Date † October 2001
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00020631
Organization ID CDR0000068675
Secondary IDs †† NCI-01-C-0143
Study Sponsor † NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators †
Principal Investigator:     Kevin Camphausen, MD     NCI - Radiation Oncology Branch; ROB    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2004
First Received Date † July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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