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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

Cisplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00003182 — Phase 1 & 2
Cisplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003182 — Phase 1 & 2
Head and Neck Cancers Research Study Groups:
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00003182 — Phase 1 & 2

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."

Answered by AI
~1 spots leftby Apr 2025