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Platinum-based Antineoplastic
Chemotherapy Combinations for Head and Neck Cancer
Phase 2
Waitlist Available
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance >/=40 ml/min determined by 24-hour collection or nomogram
Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing which of two chemotherapy combinations is better at treating head and neck squamous cell carcinoma, as well as studying the side effects of each.
Who is the study for?
Adults with advanced head and neck squamous cell carcinoma, specifically stages IV T0-4 N2b-3 M0. Participants must have good performance status (ECOG PS 0-1), adequate organ function, and measurable disease by RECIST criteria. They cannot have had prior treatments targeting EGFR pathways or radiotherapy to the head and neck, other invasive cancers (with exceptions), or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing two chemotherapy combinations: Paclitaxel, Carboplatin, Cetuximab (PCC) versus Cetuximab with Docetaxel, Cisplatin and Fluorouracil (C-TPF). It aims to determine which regimen is more effective for treating locally advanced head and neck cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of drugs like cetuximab; nerve damage; fatigue; blood count changes leading to increased infection risk; liver function alterations; kidney impairment measured by creatinine clearance; digestive issues such as nausea or mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are working well enough (creatinine clearance is at least 40 ml/min).
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I have a confirmed diagnosis of squamous cell carcinoma in my throat or mouth.
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I am fully active or can carry out light work.
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My cancer is at a stage where it affects my lymph nodes but the primary tumor size is unknown.
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I am 18 years old or older.
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My blood tests show enough white blood cells and platelets.
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My cancer is at an advanced stage but has not spread to distant organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients with Progression-Free Survival (PFS)
Trial Design
4Treatment groups
Experimental Treatment
Group I: PCC Group + RT + ChemotherapyExperimental Treatment5 Interventions
Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy
Group II: PCC Group + RTExperimental Treatment4 Interventions
Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)
Group III: C-TPF Group + RT + ChemotherapyExperimental Treatment6 Interventions
Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT) + Chemotherapy
Group IV: C-TPF Group + RTExperimental Treatment5 Interventions
Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy (RT)
2017
Completed Phase 2
~110
Cetuximab
2011
Completed Phase 3
~2480
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Fluorouracil
2014
Completed Phase 3
~11540
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,653 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,078 Previous Clinical Trials
340,744 Total Patients Enrolled
Renata Ferrarotto, MDStudy ChairM.D. Anderson Cancer Center
3 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver functions are within normal limits, except for possible Gilbert's disease.My kidneys are working well enough (creatinine clearance is at least 40 ml/min).I agree to use effective birth control during and for 3 months after treatment.I have a confirmed diagnosis of squamous cell carcinoma in my throat or mouth.I need some help with my daily activities.I have previously been treated with drugs targeting the EGFR pathway.My surgery removed all visible signs of my cancer.I do not have any other major cancers besides non-serious skin cancers.I am fully active or can carry out light work.I don't have any serious health issues that would interfere with chemotherapy.My cancer is at a stage where it affects my lymph nodes but the primary tumor size is unknown.I am 18 years old or older.My blood tests show enough white blood cells and platelets.I am not pregnant or breastfeeding.I have moderate to severe nerve damage in my hands or feet.My cancer is at an advanced stage but has not spread to distant organs.I have had radiation therapy to my head or neck.I had cancer before, but it was either non-melanoma skin cancer or treated over 3 years ago and I've been cancer-free since.My cancer is not squamous cell carcinoma.My cancer has spread to areas below my collarbone.I have had chemotherapy in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: PCC Group + RT
- Group 2: C-TPF Group + RT + Chemotherapy
- Group 3: PCC Group + RT + Chemotherapy
- Group 4: C-TPF Group + RT
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 we still able to enroll people in this research project?
"The study in question, while not recruiting at the moment, was last updated on November 8th 2022. There are currently 4,817 other clinical trials that are actively seeking participants for their research."
Answered by AI
For what purpose is Radiotherapy (RT) most commonly used?
"Radiotherapy can be an effective treatment against lymphoma and non-hodgkin. It has also been shown to help manage locally advanced non-small cell lung cancer, initial treatment, and metastatic bladder cancer."
Answered by AI
Are there many other examples of successful Radiotherapy (RT) treatments?
"Radiotherapy was first studied at City of Hope Comprehensive Cancer Center in 1997 and, to date, there have been a total of 3517 completed studies. Of these 2058 are active studies with many taking place in Houston, Texas."
Answered by AI
Are there risks commonly associated with radiation therapy?
"Radiotherapy (RT) is a treatment with some evidence for safety, but no efficacy data. This Phase 2 trial received a score of 2 from our team at Power."
Answered by AI
How many people are being welcomed into this research project?
"Unfortunately, this particular trial is not recruiting patients at the moment. Although, it's worth noting that the study was updated as recently as November 8th, 2022. If you're still interested in participating in medical research trials, there are presently 2759 trials actively searching for patients with carcinoma and 2058 trials for Radiotherapy (RT) admitting participants."
Answered by AI
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