Amifostine in Protecting the Rectum in Patients Undergoing Radiation Therapy for 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: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Kevin Camphausen, MD, Principal Investigator, Affiliation: NCI - Radiation Oncology Branch; ROB
Summary
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.
Clinical Details
Official title: Amifostine As A Rectal Protector During External Beam Radiotherapy For Prostate Cancer: A Phase II Study
Study design: Supportive Care, Open Label
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
NCI - Center for Cancer Research, Bethesda, Maryland 20892, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2002
Last updated: May 23, 2008
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