Clinical Trials/NCT01154920

NCT01154920Active, not recruitingPhase 2

Randomized Phase II Trial Contrasting Weekly Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

M.D. Anderson Cancer Center4 sites in 1 country128 target enrollmentStarted: July 9, 2010Last updated: June 12, 2026

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Active, not recruiting
Sponsor: M.D. Anderson Cancer Center
Enrollment: 128
Locations: 4
Primary Endpoint: Number of Patients with Progression-Free Survival (PFS)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•1. Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
•2. Biopsy material sufficient for HPV status determination available
•3. Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required.
•4. Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
•5. ECOG PS 0-1
•6. Age \>/= 18 years
•7. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC \>/= 1500 cells/mm\^3 and platelet count \>/= 100,000 cells/mm\^3; adequate hepatic function with bilirubin \/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male)
•9. Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
•10. Patients must sign a study-specific informed consent form

Exclusion Criteria

•Histology other than squamous cell carcinoma
•Proven distant metastases (below the clavicle) by clinical or radiographic measures
•Prior chemotherapy, within the previous 3 years
•Prior radiotherapy to the head and neck
•Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway
•Initial surgical resection rendering the patient clinically and radiologically disease free
•Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
•Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free
•Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
•Women who are pregnant or breastfeeding
•Pre-existing peripheral neuropathy CTCAE Grade 2 or worse
•Hemoglobin < 8.0g/dL
•Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Arms & Interventions

PCC Group + RT

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)

Intervention: Paclitaxel (Drug)

PCC Group + RT

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)

Intervention: Carboplatin (Drug)

PCC Group + RT

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)

Intervention: Cetuximab (Drug)

PCC Group + RT + Chemotherapy

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy

Intervention: Paclitaxel (Drug)

PCC Group + RT + Chemotherapy

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy

Intervention: Carboplatin (Drug)

PCC Group + RT + Chemotherapy

Experimental

Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy

Intervention: Cetuximab (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

Intervention: Cetuximab (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

Intervention: Docetaxel (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

Intervention: Cisplatin (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

Intervention: Fluorouracil (Drug)

C-TPF Group + RT

Experimental

Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)

Intervention: Radiotherapy (RT) (Radiation)