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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
Must not have
Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
ECOG>1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I agree to use effective birth control during and for 3 months after treatment.
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I need some help with my daily activities.
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I have previously been treated with drugs targeting the EGFR pathway.
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My surgery removed all visible signs of my cancer.
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I do not have any other major cancers besides non-serious skin cancers.
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I am not pregnant or breastfeeding.
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I have moderate to severe nerve damage in my hands or feet.
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I have had radiation therapy to my head or neck.
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My cancer is not squamous cell carcinoma.
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My cancer has spread to areas below my collarbone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Progression-Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Fluorouracil
2014
Completed Phase 3
~11700
Docetaxel
1995
Completed Phase 4
~6550
Cetuximab
2011
Completed Phase 3
~2480
Cisplatin
2013
Completed Phase 3
~3120
Paclitaxel
2011
Completed Phase 4
~5450
Radiotherapy (RT)
2017
Completed Phase 2
~110
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,219 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,113 Previous Clinical Trials
358,753 Total Patients Enrolled
Renata Ferrarotto, MDStudy ChairM.D. Anderson Cancer Center
3 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Antineoplastic) Clinical Trial Eligibility Overview. Trial Name: NCT01154920 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: PCC Group + RT, C-TPF Group + RT + Chemotherapy, PCC Group + RT + Chemotherapy, C-TPF Group + RT
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01154920 — Phase 2
Carboplatin (Platinum-based Antineoplastic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01154920 — Phase 2
~8 spots leftby Dec 2025
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