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Platinum-based Chemotherapy
AP5346 vs Oxaliplatin for Head and Neck Cancer
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must not be candidates for surgical resection or radiotherapy with curative intent
Must have evidence of progression or appearance of a new lesion after completion of radiotherapy, if biopsy site is in a previously irradiated field
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing two drugs to see which is more effective in treating 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 or cured with radiotherapy. They must have normal organ function, no severe allergies to platinum-based drugs, and not be pregnant or nursing. Participants should also not have serious heart conditions, infections, or nerve damage.Check my eligibility
What is being tested?
The study is testing two chemotherapy drugs: AP5346 and oxaliplatin. It aims to find out which drug works better at stopping the growth of tumor cells in patients with metastatic or recurrent head and neck cancer.See study design
What are the potential side effects?
Chemotherapy drugs like AP5346 and oxaliplatin may cause side effects such as nausea, fatigue, numbness in hands or feet (neuropathy), diarrhea, low blood cell counts increasing infection risk, allergic reactions, and liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Surgery or radiation cannot cure my condition.
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My cancer has grown or spread after finishing radiotherapy.
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I do not have any serious illnesses like heart failure, uncontrolled infections, or mental health issues.
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My cancer has spread and cannot be surgically removed, with no cure available.
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My cancer is a type of squamous cell carcinoma located in my head or neck.
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I can take care of myself and perform light activities.
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I do not have severe numbness, tingling, or pain in my hands or feet.
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My tumor can be biopsied with a simple procedure.
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I do not require IV feeding.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation of expression of CTR1, ATP7A, and ATP7B in SCCHN tumors with tumor platinum levels
Correlation of platinum accumulation in the tumor and tumor DNA with clinical response
Correlation of platinum accumulation in the tumor and tumor DNA with molecular response as determined by GADD153 expression
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,623 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,141 Total Patients Enrolled
William L. Read, MDStudy ChairUniversity of California, San Diego
3 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is below normal based on creatinine tests.I experience significant numbness or pain in my hands or feet.I need nutrition through an IV.Surgery or radiation cannot cure my condition.My cancer has grown or spread after finishing radiotherapy.I do not have any serious illnesses like heart failure, uncontrolled infections, or mental health issues.My cancer has spread and cannot be surgically removed, with no cure available.My cancer has returned and this has been confirmed by tests.I currently have an infection.I have symptoms of heart failure.I do not have major neurological or psychiatric issues like dementia or seizures.My cancer is a type of squamous cell carcinoma located in my head or neck.My health limits me from doing any physical work.I can take care of myself and perform light activities.I do not have severe numbness, tingling, or pain in my hands or feet.My kidney function is within normal limits.My tumor can be biopsied with a simple procedure.I do not require IV feeding.I do not have unstable chest pain or irregular heartbeats.
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 still openings to participate in this clinical research?
"As per the clinicaltrials.gov portal, this trial has been inactive since January 9th 2014 and is not currently taking on new patients. However, there are 482 other trials which require volunteers for their studies at present."
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