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Amifostine to Prevent Side Effects in Small Cell Lung Cancer Treatment
Phase 2
Waitlist Available
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status ECOG 0-1
Histologically confirmed limited stage small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well amifostine works in preventing side effects in patients with small cell lung cancer who are receiving chemotherapy and radiation therapy.
Who is the study for?
This trial is for adults over 18 with limited-stage small cell lung cancer. Participants must have normal blood counts, no active infections, and functioning liver and kidneys. They cannot be pregnant or nursing and must use effective contraception. Prior malignancies are mostly excluded except certain skin cancers or cervical carcinoma in situ.Check my eligibility
What is being tested?
The study is testing the drug Amifostine to see if it can prevent side effects in patients undergoing chemotherapy and radiation therapy for small cell lung cancer. This phase II trial aims to protect normal cells while tumor cells are targeted by treatments.See study design
What are the potential side effects?
Amifostine may cause side effects such as nausea, vomiting, low blood pressure, allergic reactions, dizziness, and a feeling of warmth or flushing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My lung cancer is confirmed to be small cell and in an early stage.
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I am over 18 years old.
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My creatinine level is below 1.5 mg/dL.
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My liver function tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,676 Total Patients Enrolled
Dean L. McCarley, MDStudy ChairVeterans Affairs Medical Center - Gainesville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My lung cancer is confirmed to be small cell and in an early stage.My treatment plan does not specify hormone therapy.I am over 18 years old.My creatinine level is below 1.5 mg/dL.My treatment plan does not specify surgery.I have never received chemotherapy.I have not undergone radiotherapy before.My liver function tests are within normal limits.My treatment plan does not specify biologic therapy.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment presently ongoing for this research endeavor?
"According to clinicaltrials.gov, this analysis is no longer enrolling participants; its post date was June 1st 1997 and it has not been revised since December 3rd 2013. However, there are presently 1770 other trials open for enrollment at present."
Answered by AI
Has this course of therapy been validated by the Food and Drug Administration?
"With a score of 2, there is evidence to suggest that this treatment has some level of safety according to our team at Power. However, Phase 2 trials do not have any data supporting efficacy as yet."
Answered by AI
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