Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments cetuximab, nab-paclitaxel, carboplatin
Phase phase 2
Target EGFR
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator Celgene Corporation
Start date February 2012
End date February 2017
Trial size 40 participants
Trial identifier NCT01412229, LCCC 1103

Summary

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cetuximab Erbitux
Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
nab-paclitaxel Abraxane
Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
carboplatin Paraplatin
Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Primary Outcomes

Measure
Clinical Response Rate Following Induction Chemotherapy
time frame: 9 weeks

Secondary Outcomes

Measure
Rate of Complete Response following Induction Chemotherapy
time frame: Baseline evaluation to 3 weeks after induction chemotherapy
Progression Free Survival and Overall Survival
time frame: 5 years
Toxicity evaluation
time frame: 2 years
Quality of Life
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed SCCHN or poorly differentiated or undifferentiated cancer of the head and neck. - Measurable disease. - All primary sites are eligible excluding nasopharyngeal. - Surgically unresectable and/or N2b or greater nodal disease; NOTE: surgical unresectability will be defined as the combination of the treating surgeon's judgment of unresectability plus one of the following objective criteria: - Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid artery. - Involvement of prevertebral musculature - Invasion of the bone of the skull base - Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient - Involvement of the cervical spine - Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection. - ECOG performance status 0-1 - Prior therapy: - Chemotherapy: No prior chemotherapy for the treatment of SCCHN. - Platinum chemotherapy: No previous history of carboplatin or cisplatin therapy. - Nab-paclitaxel: No previous treatment with nab-paclitaxel or another taxane. - Cetuximab: No previous treatment with cetuximab Or another EGFR inhibitor. - Radiation therapy: No prior radiation to the head and neck region. - Age > or = 18 years. Men and women are eligible for participation. - Must have acceptable organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration: - ANC > or = 1,500/mm3 - Platelets > or = 100,000/mm3 - HgB > 9g/dL - Total bilirubin < or = 1.5mg/dL - Albumin > 2.5 g/dL - AST(SGOT)/ALT(SGPT) < or = 2.5X institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, GFR > 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection) - No pre-existing neuropathy greater than grade I - Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to day 1 of study treatment. - Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. - Patients must have the ability to understand and the willingness to sign a written informed consent document. - Patients must have a negative result for preformed IgE antibodies to galactose-alpha-1,3,-galactose. Exclusion Criteria: - Prior treatment with any of the study medications. - Prior radiation to any of the field required to treat the tumor. - Any metastatic disease. - The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed. - Pregnant or lactating female - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac disease such as symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction will result in exclusion only if active within the past six months. Cardiac dysrhythmia will only result in exclusion if active and symptomatic (for example, rate-controlled atrial fibrillation will not result in exclusion).

Additional Information

Official title A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Principal investigator Jared Weiss, MD
Description This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy. Patients must have ECOG performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction TPF regimen which includes docetaxel, cisplatin and 5-fluorouracil (5FU).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.