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Platinum-based compound

Cisplatin-Epinephrine Gel + Chemotherapy for Recurrent Head and Neck Cancer

Phase 2

Waitlist Available

Research Sponsored by Matrix Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status: ECOG 0-2

No infection requiring parenteral antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving cisplatin-epinephrine injectable gel together with paclitaxel and carboplatin works in treating patients with head and neck cancer that has come back.

Who is the study for?

Adults with recurrent head and neck cancer, including various carcinoma types, who have relapsed after initial treatments and are not candidates for curative surgery or radiotherapy. Participants must have a measurable tumor no larger than 20 cm3 that can be injected directly under guidance and should not be at risk of major vessel invasion. They cannot join if they're under 18, in poor health, have certain blood disorders or organ dysfunction, another recent malignancy (except some skin cancers), severe allergies to trial drugs, heart disease class III/IV, infections needing IV antibiotics, or if pregnant/nursing without contraception.Check my eligibility

What is being tested?

This Phase II trial is testing the effectiveness of cisplatin-epinephrine injectable gel combined with chemotherapy drugs paclitaxel and carboplatin in patients with recurrent head and neck cancer. The goal is to see if this combination helps stop the growth of tumor cells by killing them or stopping their division.See study design

What are the potential side effects?

Potential side effects may include reactions related to chemotherapy such as nausea, fatigue, hair loss; local reactions from the injectable gel like pain or swelling; allergic responses to any component in the treatment mix; blood count changes leading to increased infection risk; and possible damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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I am not on IV antibiotics for an infection.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My cancer returned after initial treatments and I can't have surgery or radiation to cure it.

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My liver function tests are within the required ranges.

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My cancer is not threatening to spread into major blood vessels.

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I am 18 years old or older.

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My heart condition does not severely limit my daily activities.

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My cancer has returned or spread to my head, neck, or other reachable areas.

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My cancer has spread to my organs, but I can't receive cisplatin-epinephrine gel injections.

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My cancer is a recurring squamous cell type in the head or neck.

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My tumor is measurable and smaller than 20 cm3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Matrix PharmaceuticalLead Sponsor

2 Previous Clinical Trials

175 Total Patients Enrolled

Laurence Elias, MDStudy ChairMatrix Pharmaceutical

3 Previous Clinical Trials

112 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based compound) Clinical Trial Eligibility Overview. Trial Name: NCT00022217 — Phase 2

Head and Neck Cancers Research Study Groups:

Head and Neck Cancers Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00022217 — Phase 2

Carboplatin (Platinum-based compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00022217 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks should individuals be aware of while using this treatment?

"Based on the data collected, our team at Power has determined that this treatment is likely safe and gave it a score of 2. This assessment was made because we are in Phase 2 trials, meaning there is information available about safety but not effectiveness."

Answered by AI

Are there still opportunities for individuals to join this research endeavor?

"According to clinicaltrials.gov, this particular study has ceased recruitment and is no longer accepting patients into the trial. This research was initially made public on November 1st 2000 and last edited December 17th 2013; however, there are 481 other trials actively recruiting participants at present moment."

Answered by AI

How many healthcare facilities are taking part in this clinical trial?

"This clinical trial is currently running across 4 geographic locations, including Phoenix, Tucson and Evanston. Prospective participants should prioritize the closest medical facility to lessen travel burden."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer

2000. "Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00022217.

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