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Mitotic Inhibitor

Paclitaxel for Recurrent or Refractory Head and Neck Cancer

Phase 2
Waitlist Available
Research Sponsored by Theradex
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven recurrent or refractory head and neck cancer
Cardiovascular: No New York Heart Association class III-IV heart disease, No myocardial infarction within 6 months, No congestive heart failure, No unstable angina, No clinically significant pericardial effusions or arrhythmias
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is looking at how effective paclitaxel is in treating patients with head and neck cancer that has come back or didn't respond to initial treatment.

Who is the study for?
This trial is for adults with head and neck cancer that has come back or didn't respond to treatment. They must have had at least one chemotherapy before, be in relatively good health (ECOG performance status 0-2), and not have severe blood, liver, kidney, heart, or nerve problems. Pregnant women and those not using birth control are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of a chemotherapy drug called paclitaxel in patients with recurrent or refractory head and neck cancer. It's a Phase II trial which means it focuses on how well the drug works and further evaluates its safety.See study design
What are the potential side effects?
Paclitaxel can cause side effects like low blood cell counts leading to infection risk, allergic reactions due to Cremophor (a solvent used), nerve damage (neuropathy), muscle pain, joint pain, nausea, vomiting, hair loss, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My head or neck cancer has come back or is not responding to treatment.
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My heart is generally healthy with no recent major issues.
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My kidney function is within the required range and my calcium levels are normal.
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My cancer can be measured or seen on tests.
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I have had chemotherapy before for my cancer that came back or spread.
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I do not have severe numbness or pain in my hands or feet.
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My liver function tests are within normal limits.

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

Find a Location

Who is running the clinical trial?

TheradexLead Sponsor
33 Previous Clinical Trials
1,502 Total Patients Enrolled
Arlene A. Forastiere, MDStudy ChairSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
5 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Paclitaxel (Mitotic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00003327 — Phase 2
Head and Neck Cancers Research Study Groups:
Head and Neck Cancers Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT00003327 — Phase 2
Paclitaxel (Mitotic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003327 — Phase 2

Frequently Asked Questions

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

Is this medication cleared by the FDA?

"While there is some evidence that this treatment is safe, it is only in Phase 2 of clinical trials meaning that there is no data yet to support its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
1997. "Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003327.
All > Acl > Head And Neck Cancer
~2 spots leftby Apr 2025
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