C-TPF in Patients With Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of this regimen of 4 drugs and the tumor response.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Bristol-Myers Squibb
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Histologically or cytologically proven squamous cell carcinoma of the head and neck.

• Primary tumor sites eligible: oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx. Unknown primary SCC will also be eligible.

• Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound or CAT scan.

• At lease one uni- or bi-dimensionally measurable lesion by RECIST criteria.

• 18 years of age or older

• ECOG performance status of 0-1

• Adequate bone marrow, hepatic and renal functions as outlined in the protocol.

Exclusion Criteria:

• Pregnant or breast feeding women

• Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.

• Symptomatic peripheral neuropathy greater or equal to grade 2

• Symptomatic altered hearing > grade 2 by CIT-CTC criteria

• Unstable cardiac disease despite treatment, myocardial infarction within 6 months

• History of significant neurologic or psychiatric disorders including dementia or seizures

• Active clinically significant uncontrolled infection

• Active peptic ulcer disease defined as unhealed or clinically active

• Hypercalcemia

• Active drug addiction, including alcohol, cocaine or intravenous drugs use

• Chronic Obstructive Pulmonary Disease

• Autoimmune disease requiring therapy, prior organ transplant, or HIV infection

• Interstitial lung disease

• Involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry

• Concurrent treatment with any other cancer drug

• Prior EGFR therapy

• Prior severe infusion reaction to antibody therapy

• Participation in an investigational trial within 30 days of study entry