Pirfenidone in Treating Patients With Fibrosis Caused by... | NCT00020631

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

NCT00020631

Sponsor

National Cancer Institute (NCI)

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Radiation Fibrosis

Interventions

pirfenidone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-01-C-0143

Status Module

Record Verification Date

Apr 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Jul 11, 2001

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
pirfenidone	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011832	Radiation Injuries