Amifostine in Protecting the Rectum in Patients Undergoing Radiation Therapy for Prostate Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045253

Purpose

RATIONALE: Applying topical amifostine to the rectum before undergoing radiation therapy may protect healthy tissue and decrease the side effects of radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of topical amifostine in protecting the rectum in patients who are undergoing radiation therapy for prostate cancer.

Condition	Intervention	Phase
Prostate Cancer Radiation Toxicity	Drug: amifostine trihydrate Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	Amifostine As A Rectal Protector During External Beam Radiotherapy For Prostate Cancer: A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Amifostine

U.S. FDA Resources

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

Study Start Date:

June 2002

Detailed Description:

OBJECTIVES:

Determine acute rectal toxicity in patients with prostate cancer receiving topical amifostine and radiotherapy.
Determine late rectal toxicity in patients treated with this regimen.
Determine the relationship between this regimen and toxicity, quality of life, rectal dose-volume histograms, and proctoscopic examinations in these patients.

OUTLINE: Patients are stratified according to prior prostatectomy (yes vs no) and risk (low vs intermediate vs high).

Patients receive amifostine intrarectally over 30-90 seconds 30-45 minutes prior to radiotherapy 5 days a week for 7-8 weeks. Patients are advised to retain the amifostine for as long as possible (at least 20 minutes) until the radiation treatment has been delivered. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at weeks 5 and 7 during therapy, at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

Patients are followed at 1 month, every 3 months for 6 months, every 6 months for 1.5 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
No distant metastatic disease
- Negative bone scan necessary if prostate-specific antigen (PSA) is greater than 10 ng/mL or Gleason score is greater than 7

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No other active malignancy except nonmelanoma skin cancer
No chronic inflammatory bowel disease
No cognitive impairment that would preclude informed consent
No other medical condition that would preclude study participation
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent PSA vaccine allowed provided patient is also enrolled on protocol NCI-00-C-0154

Chemotherapy

No concurrent cytotoxic chemotherapy

Endocrine therapy

Concurrent anti-androgen therapy allowed for intermediate- or high-risk patients

Radiotherapy

No prior pelvic or prostatic radiotherapy

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045253

Locations

United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Simone NL, Menard C, Soule BP, Albert PS, Guion P, Smith S, Godette D, Crouse NS, Sciuto LC, Cooley-Zgela T, Camphausen K, Coleman CN, Singh AK. Intrarectal Amifostine During External Beam Radiation Therapy for Prostate Cancer Produces Significant Improvements in Quality of Life Measured by EPIC Score. Int J Radiat Oncol Biol Phys. 2007 Sep 11; [Epub ahead of print]

Muanza TM, Albert PS, Smith S, Godette D, Crouse NS, Cooley-Zgela T, Sciuto L, Camphausen K, Coleman CN, Ménard C. Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1316-21.

Menard C, Camphausen K, Muanza T, Sears-Crouse N, Smith S, Ben-Josef E, Coleman CN. Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Semin Oncol. 2003 Dec;30(6 Suppl 18):63-7.

Study ID Numbers:	CDR0000256913, NCI-02-C-0215
Study First Received:	September 6, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00045253 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

radiation toxicity
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Radiation-Protective Agents
Neoplasms
Neoplasms by Site
Amifostine
Prostatic Diseases
Genital Neoplasms, Male

Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010