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Platinum-based Chemotherapy
Cisplatin + Gemcitabine for Head and Neck Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Hope Cancer Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Upper aerodigestive tract only
Histologically proven stage III or IV squamous cell carcinoma of the head and neck that is surgically unresectable and not curable by radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well giving cisplatin together with gemcitabine works in treating patients with squamous cell cancer of the head and neck.
Who is the study for?
This trial is for adults with advanced stage III or IV squamous cell cancer of the head and neck that can't be removed by surgery or cured with radiation. The disease must be measurable or evaluable, located in the upper aerodigestive tract, and could be a recurrence after initial treatments like surgery or radiation.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining two chemotherapy drugs, cisplatin and gemcitabine, to treat patients. It's a Phase I/II trial which means they're looking at how safe the treatment is (Phase I) and how well it works (Phase II).See study design
What are the potential side effects?
Cisplatin and gemcitabine may cause side effects such as nausea, vomiting, kidney problems, hearing loss, low blood counts leading to increased infection risk or bleeding issues, fatigue, hair loss, and mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is located in the upper part of my throat, mouth, or nose.
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My cancer is advanced and cannot be removed by surgery or cured with radiation.
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My cancer cannot be removed by surgery or has come back after initial treatment.
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My cancer can be measured or seen on tests.
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My liver tests are within 3 times the normal range.
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My kidneys work well, with a creatinine clearance over 40 mL/min.
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My heart is healthy and functions well.
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I am over 18 years old.
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I can breathe well without needing extra oxygen.
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I can take care of myself and am up and about more than 50% of my waking hours.
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?
Hope Cancer Institute, Inc.Lead Sponsor
3 Previous Clinical Trials
137 Total Patients Enrolled
Raj Sadasivan, MD, PhDStudy ChairHope Cancer Institute, Inc.
3 Previous Clinical Trials
137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys work well, with a creatinine clearance over 40 mL/min.My heart is healthy and functions well.My cancer is located in the upper part of my throat, mouth, or nose.My cancer is advanced and cannot be removed by surgery or cured with radiation.My cancer cannot be removed by surgery or has come back after initial treatment.My cancer can be measured or seen on tests.My liver tests are within 3 times the normal range.I am over 18 years old.Not applicable.My blood cell levels have not been specified.I can breathe well without needing extra oxygen.I can take care of myself and am up and about more than 50% of my waking hours.
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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have any openings for participants?
"The trial's entry on clinicaltrials.gov confirms that it is not presently enrolling patients, having been initially posted in March of 1997 and last updated in December 2013. However, there are currently 480 other studies actively seeking participants."
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