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

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

May 9, 2009

Start Date ^ICMJE

October 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00020631 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

Radiation Fibrosis

Intervention ^ICMJE

Drug: pirfenidone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00020631

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068675, NCI-01-C-0143

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kevin Camphausen, MD

NCI - Radiation Oncology Branch; ROB

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP