Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT ID: NCT01412229

Last Updated: 2020-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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 Eastern Cooperative Oncology Group (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 docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer; Phase II; Locally advanced; Squamous Cell; Carboplatin; Nab-paclitaxel; Abraxane; Cetuximab; Induction; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

• nab-paclitaxel 100mg/m2
• Carboplatin area under curve (AUC)2 (IV)
• Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

Nab-paclitaxel

Intervention Type: DRUG

Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

Carboplatin

Intervention Type: DRUG

Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Interventions

Cetuximab

Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

Intervention Type: DRUG

Nab-paclitaxel

Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

Intervention Type: DRUG

Carboplatin

Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Erbitux; Abraxane; Paraplatin

Eligibility Criteria

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 epidermal growth factor receptor (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:

• Absolute Neutrophil Count (ANC) > or = 1,500/mm3
• Platelets > or = 100,000/mm3
• Hemoglobin (Hgb) > 9g/dL
• Total bilirubin < or = 1.5mg/dL
• Albumin > 2.5 g/dL
• Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < or = 2.5 times institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, glomerular filtration rate (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 immunoglobulin E (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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jared Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Related Links

http://unclineberger.org

University of North Carolina Lineberger Comprehensive Cancer Center Homepage

http://www.cancer.gov

National Cancer Institute Homepage

Other Identifiers

LCCC1103

Identifier Type: -

Identifier Source: org_study_id