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Paclitaxel, Carboplatin and Cetuximab (PCC) Versus Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

2014-08-27 03:12:30 | BioPortfolio

Summary

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.

Description

Treatment on this study consists of 2 parts. The first part of your treatment is called induction chemotherapy and will last for 6-9 weeks, depending on which group you are in. The second part of treatment will be radiation therapy (either with or without chemotherapy). The type of treatment you will receive depends on the site and stage of the disease.

Study Drugs:

Paclitaxel, carboplatin, and 5-fluorouracil are designed to block cancer cells from dividing, which may cause them to die.

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It may also damage blood vessels in tumor tissue.

Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.

Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the epidermal growth factor receptor (EGFR).

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. There is an equal chance of being assigned to either group.

- If you are in Group A, you will receive cetuximab, paclitaxel, and carboplatin.

- In you are in Group B, you will receive cetuximab, docetaxel, cisplatin, and 5-fluorouracil.

Part 1 Study Drug Administration:

Group A:

During induction, you will receive cetuximab, paclitaxel, and carboplatin by vein once a week for 6 weeks. During Week 1, the cetuximab infusion will last about 2 hours. During Weeks 2-6, the cetuximab infusion will last about 1 hour. Following the cetuximab infusion, you will receive paclitaxel over about 1 hour followed by carboplatin over about 1 hour.

Your vital signs will be monitored before, during, and after the cetuximab infusion.

Group B:

During induction, you will receive cetuximab, docetaxel, and cisplatin by vein. You will also receive 5-fluorouracil as a non-stop infusion over 4 days through an infusion pump. This pump is portable so that you can have this treatment on an outpatient basis.

On Day 1 of each 21-day cycle:

- You will receive cetuximab over about 1-2 hours.

- You will receive docetaxel over about 1 hour.

- You will receive cisplatin over about 1-3 hours

- You will then begin receiving 5-fluorouracil. This infusion will be non-stop over the next 4 days.

On Day 2 of each cycle, you will receive saline (salt water) to prevent dehydration.

On Days 5-10 of each cycle, you will take antibiotics, by mouth, to prevent infection. Your doctor will tell you what type of antibiotic to take.

On Day 8 of each cycle, you will receive cetuximab over about 1 hour.

You will have 3 cycles of induction therapy.

Other drugs may be given before you receive the study drugs to prevent side effects. You will be closely monitored for side effects during the infusions in the clinic setting before you will be allowed to leave.

Part 1 Study Visits

Every week:

You will have a physical exam, including measurement of your weight. Blood (about 3 teaspoons) will be drawn for routine tests. You will be asked about any drugs you may be taking. You will be asked about any side effects you may be having.

After you have completed your induction therapy, you will have a CT scan, MRI scan, and/or a PET-CT to check the status of the disease.

Part 2 Study Drug Administration:

Before you begin radiation, you will have a dental exam.

You will begin either radiation with chemotherapy or radiation without chemotherapy. Your doctor will decide which treatment is best for you.

All participants will begin radiation about 2-4 weeks after induction therapy. You will receive radiation Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.

If you are receiving radiation with chemotherapy, you will receive carboplatin or cisplatin every week while you are receiving radiation. If you receive cisplatin, it will be given by vein over about 1-3 hours. If you are given carboplatin, it will be given by vein over about 1 hour.

Part 2 Study Visits

Every week:

- You will have a physical exam.

- Blood (about 3 teaspoons) will be drawn for routine tests.

- Your skin and the lining of your mouth will be checked for sores.

Follow-Up Phase:

About 6 weeks after you finish all treatments:

- You will have a physical exam.

- You will have a chest x-ray.

- You will be asked about any side effects you may be having.

- You will be asked about any drugs you are taking.

- Your skin and the lining of your mouth will be checked for sores.

If you were in Group B, you will have a CT scan, MRI scan, and/or PET/CT scan at 6 weeks (+/- 10 days) after you have completed radiation/chemoradiation to check the status of the disease.

If you were in Group A, you will have a CT scan, MRI scan, and/or PET/CT scan at 9 weeks (+/- 10 days) after you have completed radiation/chemoradiation to check the status of the disease.

Six (6), 12, and 24 months after you finish treatment, you will have a videofluoroscopic to check your swallowing. You will complete a separate consent form for this procedure. You will also complete the questionnaire about your day-to-day activities.

All participants will have clinic visits every 3 months for 2 years, every 6 months through years 3 and 4, and yearly through year 5. At these visits:

- You will have a physical exam.

- You will have a chest x-ray.

- You will be asked about any side effects you may be having.

- You will be asked about any drugs you are taking.

- If your doctor thinks it is needed, you will have additional tests/procedures performed.

Length of Study:

You will remain on treatment for about 15-16 weeks. If, during that time, the disease gets worse or you experience intolerable side effects, you will be taken off study. Your participation on this study will end 5 years after you completed therapy.

This is an investigational study. All of the study drugs are FDA approved and commercially available. The combination of these drugs when given to patients with locally advanced head and neck squamous cell carcinoma is investigational.

Up to 128 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Head and Neck Squamous Cell Carcinoma

Intervention

Paclitaxel, Carboplatin, Cetuximab, Cetuximab, Docetaxel, Cisplatin, Fluorouracil, Radiotherapy (RT), Chemotherapy

Location

Dana Farber Cancer Institute
Boston
Massachusetts
United States
20115

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:30-0400

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Medical and Biotech [MESH] Definitions

A chimeric monoclonal antibody that functions as an ANTINEOPLASTIC AGENT through its binding to the EPIDERMAL GROWTH FACTOR RECEPTOR, where it prevents the binding and signaling action of cell growth and survival factors.

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

The total amount of radiation absorbed by tissues as a result of radiotherapy.

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