Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

May 9, 2009

Start Date ^ICMJE

March 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003307 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer

Official Title ^ICMJE

A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.

Detailed Description

OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the incidence and nature of toxicity associated with amifostine in these patients. III. Assess tumor response to this treatment in these patients. IV. Assess impotency rates following radiotherapy in these patients.

OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3 months for at least 5 years.

PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Prostate Cancer
Radiation Toxicity

Intervention ^ICMJE

Drug: amifostine trihydrate
Radiation: radiation therapy

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Stage T1a-T3b N0 M0 disease PSA at least 10 ng/mL prior to treatment Must have a risk of seminal vesicle involvement between 10-25% No palpable or radiographic evidence of seminal vesicle involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 24 months Hematopoietic: Not specified Hepatic: SGOT and SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cerebrovascular disease or sustained hypotension not secondary to antihypotensive medication Other: No history of inflammatory bowel disease No history of malignancy other than nonmelanoma skin cancer No underlying medical or psychiatric illness that may impair ability to participate in study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the prostate area Surgery: No prior radical prostatectomy Other: No hypertensive medications if blood pressure less than 120/70

Gender

Male

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

NCT00003307

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066254, UARIZ-HSC-9817, ALZA-98-005-ii, NCI-V98-1412

Study Sponsor ^ICMJE

University of Arizona

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

James R. Oleson, MD, PhD

University of Arizona

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2006

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