Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jul 23, 2008

Keywords

ClinConnect Summary

OBJECTIVES:

Primary

* Evaluate the progression-free survival of patients with locally advanced squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by concurrent cetuximab and radiotherapy.

Secondary

* Assess the objective response rate in patients treated with this regimen.
* Assess the best overall response rate, overall survival, local-regional control, and distant failure in patients treated with this regimen.
* Assess the acute and long-term toxicity associated with this regimen in these patients...

Gender

ALL

Eligibility criteria

• Inclusion:
• * Histologically confirmed (from primary lesion and/or lymph nodes) squamous cell carcinoma (SCC) of the head and neck, including the following subtypes:
• • Oropharynx
• • Hypopharynx
• • Larynx
• * Primary site of tumor must not include any of the following:
• • Nasopharynx
• • Sinuses
• • Salivary glands
• • Stage III or IV disease that is unresectable (oropharynx, larynx, or hypopharynx) OR that is resectable with organ-sparing goal (oropharynx or hypopharynx)
• • Measurable disease by CT scan or MRI
• • No definitive evidence of distant metastasis
• • ECOG performance status 0-1
• • ANC ≥ 1,500/μL
• • Platelet count ≥ 100,000/μL
• • Hemoglobin ≥ 8 g/dL
• • Total bilirubin ≤ normal
• • Except in the case where the elevated total bilirubin is not a sign of liver disease (i.e., Gilbert syndrome), in which case a total bilirubin ≤ 2 times upper limit of normal (ULN) is allowed provided direct bilirubin is ≤ ULN
• * AST, ALT, and alkaline phosphate (AP) meeting the following criteria:
• • AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
• • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• • AP ≤ 5 times ULN AND AST or ALT normal
• • Creatinine ≤ 1.5 mg/dL
• • Negative pregnancy test (for women of childbearing potential)
• • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• • Willing to undergo laryngoscopy with biopsy of residual tumor at primary site (as part of a comprehensive evaluation of tumor response after completion of the induction chemotherapy portion of study treatment)
• Exclusion:
• • History of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80
• • Other invasive malignancy within the past 3 years, except nonmelanoma skin cancer
• • Prior allergic reaction to the study drug(s)
• * Concurrent uncontrolled illness including, but not limited to, any of the following:
• • Ongoing or active infection
• • Psychiatric illness/social situation that would limit compliance with study requirements
• * Significant history of uncontrolled cardiac disease, including any of the following:
• • Uncontrolled hypertension
• • Unstable angina
• • Myocardial infarction within the past 6 months
• • Uncontrolled congestive heart failure
• • Cardiomyopathy with decreased left ventricular ejection fraction (i.e., LVEF \< 45%)
• • Uncontrolled condition that, in the opinion of the investigator, would interfere in the safe and timely completion of study procedures
• • History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan
• • HIV positivity
• • Pregnant or nursing
• • Prior chemotherapy for the study cancer
• • Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• • Prior chemotherapy, biological therapy, or hormone therapy within the last one year
• • Prior initial surgical treatment, except diagnostic biopsy of the primary site or nodal sampling of neck disease
• • Prior radical or modified neck dissection
• • Prior therapy that specifically and directly targets the EGFR pathway
• • Concurrent investigational agents