Study of Cetuximab and Paclitaxel for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Pembrolizumab Treatment

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What is this study about?

This clinical trial is focused on studying a type of cancer known as Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. This is a condition where cancer cells form in the tissues of the head and neck and have either returned after treatment or spread to other parts of the body. The study will explore the effects of two treatments: Cetuximab, which is a protein-based medication, and Paclitaxel, a chemical-based medication. These treatments are given as a solution through a vein, a method known as infusion.

The purpose of the study is to evaluate how effective these treatments are when given to patients who have already been treated with a combination of Pembrolizumab and chemotherapy drugs like platinum and 5-FU. Participants will be divided into two groups: one group will receive weekly doses of cetuximab combined with paclitaxel, while the other group will receive cetuximab alone. The study will monitor how well the cancer responds to these treatments.

Throughout the study, participants will receive regular infusions and undergo various assessments to track their health and the cancer’s response to the treatment. The study aims to provide valuable information on the effectiveness of these treatment options for patients with this type of head and neck cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Laboratory tests are performed to ensure adequate organ function. These tests include blood tests to check levels of neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, and kidney function.

2 treatment assignment

Participants are randomly assigned to one of two treatment groups: Arm A or Arm B.

Arm A receives a combination of cetuximab and paclitaxel. Arm B receives cetuximab alone.

3 treatment administration

Both cetuximab and paclitaxel are administered as solutions for infusion through a vein (intravenous perfusion).

Cetuximab is given weekly. If assigned to Arm A, paclitaxel is also given weekly.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests such as CT scans or MRIs to measure tumor size.

Participants are evaluated for any side effects or adverse reactions to the treatment. This is done through regular check-ups and laboratory tests.

5 completion of treatment

The study aims to continue treatment until disease progression or unacceptable side effects occur.

Participants are followed up for health-related quality of life assessments and overall survival rates.

Who Can Join the Study?

Sign a written and voluntary informed consent form.
Have proper organ function, which will be checked through blood tests before starting treatment. This includes:
- Enough white blood cells called neutrophils.
- Adequate number of platelets, which help with blood clotting.
- Proper levels of hemoglobin, a protein in red blood cells that carries oxygen.
- Normal levels of bilirubin, a substance made during the breakdown of red blood cells.
- Normal levels of liver enzymes called AST and ALT.
- Normal kidney function, measured by creatinine levels or creatinine clearance, which shows how well the kidneys are working.
For women, proof of being post-menopausal or a negative pregnancy test if pre-menopausal. Post-menopausal means not having periods for 12 months without another medical reason.
Women who can have children must have a negative pregnancy test before starting the study and agree to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity during the study and for 180 days after the last dose of study medication.
Men must agree to use a reliable method of birth control starting with the first dose of study therapy and for 180 days after the last dose. Abstinence is acceptable if it is their usual lifestyle.
Be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
Be older than 18 years.
Have a confirmed diagnosis of head and neck squamous cell carcinoma, a type of cancer.
The primary tumor must be located in the oropharynx, oral cavity, hypopharynx, or larynx.
Have known Human papillomavirus (HPV) status for oropharyngeal tumors, tested by specific methods like p16 or HPV DNA testing.
Show disease progression after receiving specific treatments (platinum/5-FU and pembrolizumab) for recurrent or metastatic disease. The disease must be measurable by CT or MRI scans.
Provide a tumor biopsy before starting the study treatment. A new biopsy after disease progression is preferred, but an older sample may be acceptable if discussed with the sponsor.
Have a performance status of 0 or 1 on the ECOG Performance Scale, which measures the ability to perform daily activities.

Who Cannot Join the Study?

Patients who have not been diagnosed with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck cannot participate. This is a type of cancer that occurs in the head and neck area and has either come back after treatment or spread to other parts of the body.
Patients who have not previously been treated with pembrolizumab plus platinum/5-FU are excluded. Pembrolizumab is a medication used to help the immune system fight cancer, and platinum/5-FU are types of chemotherapy drugs.
Individuals who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are considered part of a vulnerable population are not eligible. This means people who might be at higher risk of harm or exploitation, such as children or those unable to give informed consent, are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hospital Universitario De Toledo Ute	Toledo	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Centro Oncologico De Galicia	A Coruna Galicia	Spain
Hrxdgpvj Uvxciryrsuiyc Mpeybfg Di Vtzkltemwv	Santander	Spain
Iagkjmtz Ceqwwq Dqvrkngntwvmkofig	L'hospitalet De Llobregat	Spain
Hpswrtob Uxsduraazdtsi Rmvdkohs Dg Mnknoz	Malaga	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	15.02.2025

Trial locations

Investigated drugs:

Cetuximab is a medication used in this study to treat patients with a type of cancer called squamous cell carcinoma of the head and neck. It works by targeting specific proteins on the surface of cancer cells, which can help slow down or stop the growth of the cancer.

Paclitaxel is another medication used in combination with cetuximab in this study. It is a type of chemotherapy that helps stop cancer cells from dividing and growing. It is given to patients who have not responded to initial treatments.

Pembrolizumab is a medication that was used in the first-line treatment before the study. It is an immunotherapy drug that helps the immune system recognize and attack cancer cells.

Platinum refers to a group of chemotherapy drugs that contain the metal platinum. These drugs are used to damage the DNA of cancer cells, which can lead to their death.

5-FU (5-Fluorouracil) is a chemotherapy medication that was part of the initial treatment. It works by interfering with the DNA and RNA of cancer cells, preventing them from growing and dividing.

Investigated diseases:

Squamous cell carcinoma of head and neck

Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It is characterized by the abnormal growth of these cells, which can form tumors. When the cancer returns after treatment, it is termed recurrent, and when it spreads to other parts of the body, it is called metastatic. The disease often progresses by invading nearby tissues and can spread to lymph nodes and other organs. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. The progression can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-514953-31-00

Protocol code:

TTCC-2022-02

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Cetuximab and Paclitaxel for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Pembrolizumab Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?