A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT00415194Tipo: INTERVENTIONALInicio: 1 de dic de 2006Fin estimado: 1 de mar de 2010

Traducción no disponible, mostrando original

Resumen

This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.
You must have a performance status of 0,1 or 2. This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.
Your test results must show that your liver, kidneys and blood cells are working normally.
You must understand and sign the form that gives your agreement to willingly be part of the study.
You must be at least 18 years of age.

Criterios de exclusión

You cannot have previously been given other treatment for cancer that has spread to other parts of your body.
You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).
You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.
You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.
If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.

Intervenciones

drug

pemetrexed

500 mg/m\^2, IV, every 21 days, six 21 day cycles

drug

cisplatin

75 mg/m\^2, administered IV, every 21 days, six 21 day cycles

drug

placebo

Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

S.M. de Tucuman, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Santa Fé, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tucumain, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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