Clinical Trial VICCTHN1340
A Phase II Study of Carboplatin, Nab-Paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Protocol No. VICCTHN1340
- Open Date: 10/14/2013
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: Estimate the overall objective response rate (CR+PR) after induction chemotherapy with nab-paclitaxel, carboplatin and cetuximab in patients with unresectable and/or >/= N2b locally advanced SCCHN who are considered appropriate candidates for an induction approach.
- Disease Sites: Head/Neck
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Carboplatin; Cetuximab; Cetuximab (Erbitux); Nab-paclitaxel
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01412229
- Secondary Protocol No: LCCC 1103
Patients are being asked to take part in this research study because they have cancer of the head and neck (specifically squamous cell carcinoma of the head and neck (SCCHN)) that cannot be cured with surgery alone. Approximately 60% of SCCHN patients that have disease that has spread locally, but not to distant sites, are candidates for combined therapy, including surgery, chemotherapy and radiation. Unfortunately, less than half of locally-advanced cases will be cured with standard treatments including surgery, radiotherapy and chemotherapy. The purpose of this research study is to determine whether substituting paclitaxel with nab-paclitaxel will improve the disease response rate with less toxicity than the most commonly used induction chemotherapy regimen, which includes docetaxel, cisplatin and 5-fluorouracil (5-FU).
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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.
• 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).