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

NCT01154920 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2009-0885NCI-2012-01773
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; HNSCC; Paclitaxel; Carboplatin; Cetuximab; Docetaxel; Taxotere; Cisplatin; Platinol-AQ; Platinol; CDDP; Fluorouracil; 5-FU; Adrucil; Efudex; chemotherapy; radiation; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Progression-Free Survival (PFS)

  PFS defined as the time from the first day of treatment until the date of objective progressive disease (PD) (locoregional or distant) or death (by any cause in the absence of PD is first reported.

  2 Years

Study Arms (4)

PCC Group + RT

EXPERIMENTAL

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

Drug: Paclitaxel; Drug: Carboplatin; Drug: Cetuximab; Radiation: Radiotherapy (RT)

PCC Group + RT + Chemotherapy

EXPERIMENTAL

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

Drug: Paclitaxel; Drug: Carboplatin; Drug: Cetuximab; Radiation: Radiotherapy (RT); Other: Chemotherapy

C-TPF Group + RT

EXPERIMENTAL

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

Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiotherapy (RT)

C-TPF Group + RT + Chemotherapy

EXPERIMENTAL

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

Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiotherapy (RT); Other: Chemotherapy

Interventions

Carboplatin DRUG

AUC of 2 weekly, Weeks 1 - 6

Also known as: Paraplatin

PCC Group + RT; PCC Group + RT + Chemotherapy

Cetuximab DRUG

PCC Arm: 400 mg/m\^2 by vein over about 1-2 hours on Day 1; 250 mg/m\^2 weeks 2 - 6. C-TPF Arm: 250 mg/m2 weeks 2, 4, 5, 7 and 8.

Also known as: Erbitux, C225, IMC-C225

C-TPF Group + RT; C-TPF Group + RT + Chemotherapy; PCC Group + RT; PCC Group + RT + Chemotherapy

Docetaxel DRUG

75 mg/m\^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy

Also known as: Taxotere

C-TPF Group + RT; C-TPF Group + RT + Chemotherapy

Paclitaxel DRUG

135 mg/m\^2 weekly, Weeks 1 - 6

Also known as: Taxol

PCC Group + RT; PCC Group + RT + Chemotherapy

Cisplatin DRUG

100 mg/m\^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy

Also known as: Platinol-AQ, Platinol, CDDP

C-TPF Group + RT; C-TPF Group + RT + Chemotherapy

Fluorouracil DRUG

700 mg/m\^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy

Also known as: 5-Fluorouracil, 5-FU, Adrucil, Efudex

C-TPF Group + RT; C-TPF Group + RT + Chemotherapy

Radiotherapy (RT) RADIATION

Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.

Also known as: Radiation Therapy, RT

C-TPF Group + RT; C-TPF Group + RT + Chemotherapy; PCC Group + RT; PCC Group + RT + Chemotherapy

Chemotherapy OTHER

PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m\^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.

Also known as: Chemoradiotherapy

C-TPF Group + RT + Chemotherapy; PCC Group + RT + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
• Biopsy material sufficient for HPV status determination available
• 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.
• Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
• ECOG PS 0-1
• Age \>/= 18 years
• 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 \</= ULN (excluding Gilbert's disease), AST and ALT may be up to 2.5 x ULN if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 x ULN if AST and ALT are normal. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
• Creatinine clearance \>/=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)
• 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.
• Patients must sign a study-specific informed consent form

You may not qualify if:

• Histology other than squamous cell carcinoma
• Proven distant metastases (below the clavicle) by clinical or radiographic measures
• ECOG\>1
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 20115, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Paclitaxel; Carboplatin; Cetuximab; Docetaxel; Cisplatin; Fluorouracil; Radiotherapy; Drug Therapy; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Combined Modality Therapy

Study Officials

• Renata Ferrarotto, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: July 9, 2010
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-11

Locations

US (2)