Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Neoplasms, Squamous Cell

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

Cetuximab 750 mg/m\^2 IV over 3 hours every other week

cetuximab

Matthew Fury, MD,PhD

The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.

Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m^2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.

Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam

Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.

Eli Lilly and Company

National Comprehensive Cancer Network

Memorial Sloan Kettering Cancer Center

Cetuximab infusion at 500 mg/m2 over 2 hours every other week.

Arm A

Cetuximab infusion at 750 mg/m2 over 3 hours every other week.

Arm B

Total

Age, Categorical

Sex: Female, Male

For safety data please see adverse events

Dr. David Pfister

Partial Response (PR)

Stable Disease (SD)

Progression of Disease (POD)

Number of Patients With Overall Objective Response

The Total Number of Participants That Were Effected by Adverse Events.

Cetuximab infusion at 500 mg/m\^2 over 2 hours every other week.

Cetuximab Infusion at 500 mg/m^2

Cetuximab infusion at 750 mg/m\^2 over 3 hours every other week.

Spots Global Cancer Trial Database for Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

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Useful links and downloads for this trial