Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)

NCT00343083 | Completed Phase 2 Results DMC

• 2 other identifiers: HP-00042712CA225092
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the response of the tumor to the treatment regimen that will be used in this study. This study will also test the safety of cetuximab (C225), given with chemotherapy and radiation therapy. We also want to see what effects (good and bad) cetuximab, chemotherapy, and radiation therapy have head \& neck cancer. C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways that lead to tumor cell growth. In prior studies with head \& neck cancer patients, C225 has delayed tumor growth and provided relief of symptoms in some patients.

Conditions

Cancer of Head and Neck

Keywords

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.

  The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.

  3 months

Secondary Outcomes (5)

• Local Regional Control at 2 Years

  2 years

• Overall Survival and Disease-free Survival

  3 years (overall) 2 years disease-free

• Pathological Response to Cetuximab

  2 years

• Percentage of Participants With Grade 3 Toxicities of Cetuximab

  9 weeks

• Clinical Complete Response Rate of This Regimen in the Population

  3 months

Study Arms (1)

Cetuximab comparison for Head and Neck Cancer

EXPERIMENTAL

To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT). Both chemotherapy and radiation will be given on a weekly basis (see interventions for details).

Drug: Erbitux, Paclitaxel & Carboplatin; Radiation: Radiation

Interventions

Erbitux, Paclitaxel & Carboplatin DRUG

Paclitaxel, 40 mg/m2/week, 1-hour infusion (weeks 2-9.Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose. Cetuximab: 400 mg/m2 IV (initial dose) week 1 then 250 mg/m2 IV weekly for 8 weeks weeks 2-9). Cetuximab will be administered 400mg/m2 IV on Day 1, then the first 250 mg/m2 IV dose will be given on day 8 (week 2) prior to carboplatin dose. Carboplatin, AUC=2/week as a 30 minute infusion after cetuximab infusion (weeks 2-9)Carboplatin will be administered at a dose of AUC = 2/week IV bolus each week and will be administered prior to head and neck irradiation dose. (Carboplatin: AUC=2/week x 8 weeks (weeks 2-9)

Also known as: Taxol, Erbitux

Cetuximab comparison for Head and Neck Cancer

Radiation RADIATION

XRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed

Cetuximab comparison for Head and Neck Cancer

Eligibility Criteria

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

You may qualify if:

• Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses, Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses- T4 N0 N1 N2-A,B,C N3, T3 N0 N1 N2-A,B,C N3 Any T N2-A,B,C N3 Unknown primary Tx N2-A,B,C N3 Note: Only clearly unresectable T4 N0 lesions are eligible for study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon
• Patients must have signed an approved informed consent.
• Patients with Performance Status 0-2.
• No evidence of distant metastatic disease.
• No previous radiation therapy.
• No previous chemotherapy.
• Patients must be greater than 18 years of age.
• Women of child bearing potential (WOCBP) must have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• Pretreatment evaluations include:
• History and physical examination within four weeks prior to study entry Dental evaluation Medical oncology examination to evaluate medical contraindications prior to start of chemotherapy
• Adequate renal \& bone marrow function determined by the following laboratory parameters:
• ANC greater than or equal to 1500/mm3; platelets greater than or equal to 100,000/mm3; hemoglobin greater than or equal to 8.0 g/dl; Serum Creatinine less than or equal to 2.0 mg/dl, Total bilirubin less than 1.5 X the ULIN; AST/ALT less than 3 times the ULN, Creatinine Clearance greater than or equal to 50 cc/min
• Evidence of measurable disease.
• No evidence of concomitant malignancy except for non-melanomatous skin cancer (controlled or controllable) or carcinoma in situ of the cervix.

You may not qualify if:

• Any of the following criteria will make the patient ineligible to participate in this study:
• Acute hepatitis or known HIV.
• Active or uncontrolled infection.
• Significant history of concomitant life threatening / uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and known cardiomyopathy with decreased ejection fraction, cardiac arrhythmia
• Prior therapy which specifically and directly targets the EGFR pathway.
• Prior severe infusion reaction to a monoclonal antibody.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
• Women of childbearing potential (WOCBP) and male participants who are unwilling or unable to use an effective method to avoid pregnancy for the entire study period
• Preexisting clinically significant neuropathy.
• Patients with loco-regional recurrences from any site with no prior radiation therapy and not amenable for salvage surgery are not eligible for study.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Maryland & Baltimore VA medical centre

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab; Paclitaxel; Carboplatin; Radiation

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Physical Phenomena

Results Point of Contact

• Title: Ritesh Kataria
• Organization: University of Maryland Baltimore

rkataria@umm.edu

410-328-8018

Study Officials

• Mohan Suntharalingam, M.D

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2006
• First Posted: June 22, 2006
• Study Start: December 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: May 1, 2012
• Last Updated: August 19, 2019
• Results First Posted: April 9, 2014

Record last verified: 2019-08

Locations

US (1)