128 Participants Needed

Chemotherapy Combinations for Head and Neck Cancer

Recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the chemotherapy combination for head and neck cancer safe for humans?

The chemotherapy combinations involving drugs like docetaxel, cisplatin, 5-fluorouracil, carboplatin, and cetuximab have been studied for head and neck cancer. While they can be effective, they may cause severe side effects such as neutropenia (a low level of white blood cells, which can increase infection risk). Safety varies, and some combinations are generally considered feasible, but side effects can limit treatment adherence.12345

What makes this drug combination unique for head and neck cancer?

This drug combination is unique because it includes a mix of chemotherapy agents like docetaxel, cisplatin, and cetuximab, which have shown strong antitumor activity and radiopotentiating properties, potentially enhancing the effectiveness of radiotherapy. Additionally, using carboplatin instead of cisplatin may reduce toxicity, making the treatment more tolerable for patients.23467

What data supports the effectiveness of the drug combination for head and neck cancer?

Research shows that combinations of cisplatin or carboplatin with 5-fluorouracil and cetuximab are more effective than using cisplatin or carboplatin with 5-fluorouracil alone for treating head and neck cancer. Additionally, docetaxel and cisplatin are known to be active against this type of cancer, and cetuximab combined with these drugs has shown promising results.23458

Who Is on the Research Team?

RF

Renata Ferrarotto, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion 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 have a confirmed diagnosis of squamous cell carcinoma in my throat or mouth.
See 9 more

Exclusion Criteria

I agree to use effective birth control during and for 3 months after treatment.
I need some help with my daily activities.
I have previously been treated with drugs targeting the EGFR pathway.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy with either PCC or C-TPF regimen

6-9 weeks
Weekly visits for drug administration and monitoring

Radiation Therapy

Participants receive radiation therapy, with or without chemotherapy, based on the treatment group

7 weeks
Daily visits Monday through Friday

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Clinic visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Cetuximab
  • Cisplatin
  • Docetaxel
  • Fluorouracil
  • Paclitaxel
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: PCC Group + RT + ChemotherapyExperimental Treatment5 Interventions
Group II: PCC Group + RTExperimental Treatment4 Interventions
Group III: C-TPF Group + RT + ChemotherapyExperimental Treatment6 Interventions
Group IV: C-TPF Group + RTExperimental Treatment5 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
🇪🇺
Approved in European Union as Carboplatin for:
🇨🇦
Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

Published Research Related to This Trial

The combination of carboplatin, oral tegafur, and cetuximab is a safe and well-tolerated first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), with a high compliance rate among patients.
In a study of 104 patients, the treatment resulted in a median overall survival of 11 months and a progression-free survival of 6 months, with an overall response rate of 35%, indicating its efficacy in managing this type of cancer.
Intravenous 5-Fluorouracil in Patients With Advanced Squamous Cell Carcinoma: A Retrospective Study.Buxó, E., Sosa, A., Reig, O., et al.[2019]
The new chemotherapy regimen combining docetaxel, cisplatin, and cetuximab (B-CRT) for treating locally advanced head and neck squamous cell carcinoma resulted in severe neutropenia in 56% of patients, indicating significant safety concerns.
Due to the high incidence of adverse events, particularly neutropenia and leukopenia, the study was terminated early, and it remains unclear if B-CRT is as effective as the standard TPF-CRT regimen.
Phase II trial of concurrent bio-chemoradiotherapy using docetaxel, cisplatin, and cetuximab for locally advanced head and neck squamous cell carcinoma.Nishimura, G., Taguchi, T., Takahashi, M., et al.[2018]
The TPEx regimen, which combines docetaxel, cisplatin, and cetuximab, achieved an objective response rate of 44.4% in 54 patients with recurrent or metastatic head and neck squamous cell carcinoma, indicating promising efficacy as a first-line treatment.
While the treatment was generally well-tolerated, notable adverse events included skin rash (16.6%) and non-febrile neutropenia (20.4%), with some serious complications leading to death, highlighting the need for careful monitoring during therapy.
Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study.Guigay, J., Fayette, J., Dillies, AF., et al.[2022]

Citations

Intravenous 5-Fluorouracil in Patients With Advanced Squamous Cell Carcinoma: A Retrospective Study. [2019]
Phase II trial of concurrent bio-chemoradiotherapy using docetaxel, cisplatin, and cetuximab for locally advanced head and neck squamous cell carcinoma. [2018]
Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. [2022]
Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. [2020]
Current recommendations for systemic therapy of recurrent and/or metastatic head and neck squamous cell cancer. [2019]
Comparison of carboplatin-paclitaxel to docetaxel-cisplatin-5-flurouracil induction chemotherapy followed by concurrent chemoradiation for locally advanced head and neck cancer. [2021]
Carboplatin in combination with raltitrexed in recurrent and metastatic head and neck squamous cell carcinoma: A multicentre phase II study of the Gruppo Oncologico Dell'Italia Meridionale (G.O.I.M.). [2014]
New cytostatic agents for the treatment of head and neck cancer. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security