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

NCT01412229 | Completed Phase 2 Results DMC

• 1 other identifier: LCCC1103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Response Rate Following Induction Chemotherapy

  Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

  9 weeks

Secondary Outcomes (8)

• Rate of Complete Response Following Induction Chemotherapy

  Baseline evaluation to 3 weeks after induction chemotherapy

• Progression Free Survival

  1 year

• Objective Response Rate (CR+PR)

  20 weeks

• Complete Response Rate (CR)

  20 weeks

• Overall Survival

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Cetuximab; Drug: Nab-paclitaxel; Drug: Carboplatin

Interventions

Cetuximab DRUG

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

Also known as: Erbitux

Treatment

Nab-paclitaxel DRUG

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

Also known as: Abraxane

Treatment

Carboplatin DRUG

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

Also known as: Paraplatin

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (3)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98194, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Homepage
• National Cancer Institute Homepage

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Coordination Complexes

Results Point of Contact

• Title: Robin Johnson
• Organization: UNC Lineberger

Robin_V_Johnson@med.unc.edu

(919) 966-1125

Study Officials

• Jared Weiss, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 9, 2011
• Study Start: February 1, 2012
• Primary Completion: June 20, 2015
• Study Completion: December 1, 2019
• Last Updated: November 23, 2020
• Results First Posted: July 2, 2017

Record last verified: 2020-09

Locations

US (3)