Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer; Radiation Toxicity
Intervention: amifostine trihydrate (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Arizona Official(s) and/or principal investigator(s):
James R. Oleson, MD, PhD, Study Chair, Affiliation: University of Arizona
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.
Clinical Details
Official title: 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
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Arizona Cancer Center, Tucson, Arizona 85724, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 1998
Last updated: May 23, 2008
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