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Erbitux, Paclitaxel & Carboplatin

Phase 2

Cancer of Head and Neck | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 19, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

Erbitux, Paclitaxel & Carboplatin · 1 trial · 1 indication

Phase 2 1
NCT00343083Evaluation 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)Cancer of Head and Neck
COMPLETED43 Analytics
PHASE2COMPLETED
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)
Cancer of Head and NeckUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cetuximab comparison for Head and Neck CancerEXPERIMENTALTo 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).

Interventions

NameTypeDescription
Erbitux, Paclitaxel & CarboplatinDRUGPaclitaxel, 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)
RadiationRADIATIONXRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. 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 sinu...

Countries:United States
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Frequently asked questions about Erbitux, Paclitaxel & Carboplatin

What is Erbitux, Paclitaxel & Carboplatin used for?

Erbitux, Paclitaxel & Carboplatin is a combination regimen being studied for the treatment of cancer of the head and neck. It is in Phase 2 clinical development and is being evaluated in patients with advanced locoregional squamous cell carcinomas of the head and neck.

Who makes Erbitux, Paclitaxel & Carboplatin?

Erbitux, Paclitaxel & Carboplatin is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this combination regimen for head and neck cancer.

What phase is Erbitux, Paclitaxel & Carboplatin in?

Erbitux, Paclitaxel & Carboplatin is in Phase 2 clinical development. It is an investigational combination regimen and has not been approved by the FDA. One Phase 2 trial has been completed for this regimen in head and neck cancer.

What clinical trials is Erbitux, Paclitaxel & Carboplatin in?

Erbitux, Paclitaxel & Carboplatin has one completed clinical trial, NCT00343083. This Phase 2 study evaluated the combination of cetuximab (Erbitux) with concurrent carboplatin, paclitaxel, and radiotherapy in patients with advanced locoregional squamous cell carcinomas of the head and neck. The trial enrolled 43 participants in the United States.

Is Erbitux, Paclitaxel & Carboplatin the same as cetuximab?

Erbitux, Paclitaxel & Carboplatin is a combination regimen that includes cetuximab, which is also known as Erbitux. The regimen combines cetuximab with the chemotherapy drugs paclitaxel and carboplatin, and is being studied for head and neck cancer.