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Chemotherapy Agent
Amifostine + Chemo/Radiation for Head and Neck Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease
Hepatic: Bilirubin no greater than 2.5 times normal, SGOT and SGPT no greater than 2.5 times upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects of giving amifostine together with cisplatin, paclitaxel, and radiation therapy in treating patients with head and neck cancer.
Who is the study for?
This trial is for adults with advanced head and neck cancer that can't be removed by surgery. Participants must have a certain level of physical fitness, adequate blood cell counts, normal liver function, and proper kidney function. They should not be pregnant or nursing and must agree to use contraception. Those who've had recent chemotherapy or radiation therapy in the head and neck area are excluded.Check my eligibility
What is being tested?
The study is testing whether amifostine combined with cisplatin, paclitaxel (chemotherapy drugs), and radiation therapy is effective in treating patients with advanced unresectable head and neck cancer. It's a Phase I/II trial which means it's looking at the safety of this combination as well as its potential effectiveness.See study design
What are the potential side effects?
Possible side effects include damage to healthy cells leading to symptoms like nausea, vomiting, fatigue; increased risk of infections due to low blood cell counts; liver problems indicated by changes in specific blood tests; kidney issues reflected by creatinine levels; plus other general drug-related adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer in the head or neck area is confirmed and cannot be removed by surgery.
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My liver tests are within acceptable limits.
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My kidney function is good, with creatinine levels not exceeding 1.5 mg/dL.
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I am mostly self-sufficient and can carry out daily activities.
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I am 18 years old or older.
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
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,310 Total Patients Enrolled
Fred R. Rosen, MDStudy ChairUniversity of Illinois at Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over a day since I last took my blood pressure medicine.My cancer in the head or neck area is confirmed and cannot be removed by surgery.It has been over a month since my last chemotherapy session.It's been over 3 months since I had radiotherapy to my head or neck.My liver tests are within acceptable limits.My kidney function is good, with creatinine levels not exceeding 1.5 mg/dL.My treatment plan for biologic therapy is not decided.I am mostly self-sufficient and can carry out daily activities.I am 18 years old or older.My treatment plan does not specify endocrine therapy.Surgery requirements are not specified for this trial.
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.
Are there any opportunities for individuals to partake in this research?
"Clinicaltrials.gov confirms that this trial, initially posted on December 1st 1997 and last revised in 2013, is not currently recruiting patients. However, there are 541 other trials accepting participants at present."
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