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A Study for Patients With Head and Neck Cancer

23 de junio de 2011 actualizado por: Eli Lilly and Company

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

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

Descripción general del estudio

Estado

Terminado

Condiciones

Neoplasias de Cabeza y Cuello

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

795

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Alemania
- - Berlin, Alemania, 13125
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  - Erlangen, Alemania, D-91054
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  - Essen, Alemania, 45122
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  - Frankfurt, Alemania, D-65929
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  - Hannover, Alemania, 30625
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  - Heidelberg, Alemania, 69120
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  - Leipzig, Alemania, 04103
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  - Luebeck, Alemania, 23538
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Argentina
- - Buenos Aires, Argentina, C1185AAT
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  - S.M. De Tucuman, Argentina, 4000
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  - Santa Fé, Argentina, 3000
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  - Tucumain, Argentina, 4000
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Brasil
- - Belo Horizonte, Brasil, 30140-083
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  - Rio De Janeiro, Brasil, 20231050
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Bélgica
- - Antwerp, Bélgica, 2020
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  - Edegem, Bélgica, 2650
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Corea, república de
- - Daegu, Corea, república de, 700-721
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  - Hwasun-Gun, Corea, república de, 519-809
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  - Pusan, Corea, república de, 609 735
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  - Seoul, Corea, república de, 134-791
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Dinamarca
- - Aarhus, Dinamarca, 8000
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  - Odense, Dinamarca, 5000
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España
- - Barcelona, España, 08036
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  - Madrid, España, 28041
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  - Murcia, España, 30008
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  - Pamplona, España, 31008
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  - Sevilla, España, 41013
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  - Valencia, España, 46014
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Estados Unidos
- California
  - Orange, California, Estados Unidos, 92868
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- Florida
  - Orlando, Florida, Estados Unidos, 32806
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  - St. Petersburg, Florida, Estados Unidos, 33708
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- Georgia
  - Atlanta, Georgia, Estados Unidos, 30322
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- Illinois
  - Chicago, Illinois, Estados Unidos, 60637
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- Indiana
  - Beech Grove, Indiana, Estados Unidos, 46107
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- Kansas
  - Wichita, Kansas, Estados Unidos, 67214
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- Kentucky
  - Louisville, Kentucky, Estados Unidos, 40202
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- Michigan
  - Ann Arbor, Michigan, Estados Unidos, 48109
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- Minnesota
  - Minneapolis, Minnesota, Estados Unidos, 55455
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- Missouri
  - St Louis, Missouri, Estados Unidos, 63110
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- New York
  - Stony Brook, New York, Estados Unidos, 11794
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- North Carolina
  - Chapel Hill, North Carolina, Estados Unidos, 27599
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- Oklahoma
  - Oklahoma City, Oklahoma, Estados Unidos, 73112
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- Rhode Island
  - North Smithfield, Rhode Island, Estados Unidos, 02896
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Federación Rusa
- - Barnaul, Federación Rusa, 656049
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  - Chelyabinsk, Federación Rusa, 454087
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  - Moscow, Federación Rusa, 115478
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  - Murmansk, Federación Rusa, 183047
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  - Saint Petersburg, Federación Rusa, 198255
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Francia
- - Avignon, Francia, 84082
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  - Tours, Francia, 37044
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Hungría
- - Budapest, Hungría, 1122
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  - Nyiregyhaza, Hungría, H-4400
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India
- - Bangalore, India, 560 029
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  - Bhopal, India, 462001
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  - Hyderabaad, India, 500034
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  - Jaipur, India, 302013
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  - Kochin, India, 682304
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  - Kolkata, India, 700053
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  - New Delhi, India, 110 029
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  - Patna, India, 801505
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  - Pune, India, 411004
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  - Trivandrum, India, 695 011
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Italia
- - Confreria, Italia, 12100
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  - Genova, Italia, 16132
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  - Milano, Italia, 20133
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  - Padova, Italia, 35128
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México
- - Durango, México, 34208
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  - Mexico City, México, 15900
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  - Michoacan, México, 58080
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  - Monterrey, México
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  - Roma Sur, México, 06760
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  - Toluca, México, CP50180
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Países Bajos
- - Amsterdam, Países Bajos, 1081 HV
    - 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.
  - Nijmegen, Países Bajos, 6500 HB
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Polonia
- - Gdansk, Polonia, 80-211
    - 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.
  - Krakow, Polonia, 31-531
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  - Olsztyn, Polonia, 10-228
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  - Warsaw, Polonia, 02-781
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Porcelana
- - Guang Zhou, Porcelana, 510060
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  - Nanning, Porcelana, 530000
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  - Shanghai, Porcelana, 200032
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  - Wu Han, Porcelana, 430030
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Puerto Rico
- - San Juan, Puerto Rico, 00935
    - 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.
Rumania
- - Bucharest, Rumania, 022328
    - 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.
  - Cluj-Napoca, Rumania, 3400
    - 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.
  - Oradea, Rumania, 3700
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  - Targu Mures, Rumania, 540136
    - 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.
Sudáfrica
- - Bloemfontein, Sudáfrica, 9300
    - 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.
  - Durban, Sudáfrica, 4091
    - 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.
  - Parktown, Sudáfrica, 2193
    - 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.
Taiwán
- - Changhua, Taiwán, 500
    - 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.
  - Hualien, Taiwán, 970
    - 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.
  - Liouying/Tainan, Taiwán, 736
    - 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.
  - Taipei, Taiwán, 112
    - 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.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Cuadruplicar

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: Pemetrexed/Cisplatin Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.	Droga: pemetrexed 500 mg/m^2, IV, every 21 days, six 21 day cycles Otros nombres: Alimata LY231514 Droga: cisplatin 75 mg/m^2, administered IV, every 21 days, six 21 day cycles
Comparador de placebos: Placebo/Cisplatin Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.	Droga: cisplatin 75 mg/m^2, administered IV, every 21 days, six 21 day cycles Droga: placebo Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: Pemetrexed/Cisplatin

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Droga: pemetrexed

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

Otros nombres:

Alimata
LY231514

Droga: cisplatin

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

Comparador de placebos: Placebo/Cisplatin

Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Droga: cisplatin

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

Droga: placebo

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Overall Survival (OS) Periodo de tiempo: Baseline to date of death from any cause up to 36 months	OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.	Baseline to date of death from any cause up to 36 months

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Progression-free Survival (PFS) Periodo de tiempo: baseline to measured progressive disease up to 33 months	Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.	baseline to measured progressive disease up to 33 months
Percent of Participants With a Tumor Response (Response Rate) Periodo de tiempo: Baseline to progressive disease or discontinuation of study treatment up to 11 months	Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100	Baseline to progressive disease or discontinuation of study treatment up to 11 months
Duration of Response (DoR) Periodo de tiempo: time of response to progressive disease up to 24 months	DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.	time of response to progressive disease up to 24 months
Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score Periodo de tiempo: Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months	FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.	Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
Correlation Between Biomarkers and Treatment Effect Periodo de tiempo: Baseline	Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first. 0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data.	Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2006

Finalización primaria (Actual)

1 de marzo de 2010

Finalización del estudio (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

20 de diciembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

21 de diciembre de 2006

Publicado por primera vez (Estimar)

22 de diciembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de junio de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2011

Última verificación

1 de junio de 2011

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

8431
H3E-MC-JMHR (Otro identificador: Eli Lilly and Company)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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Terminado

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Shanghai Shengdi Pharmaceutical Co., Ltd

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National Natural Science Foundation of China

Desconocido

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Metástasis cerebrales

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Desconocido

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Linfoma | Tumores cerebrales y del sistema nervioso central | Cáncer metastásico

Estados Unidos
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Terminado

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Estados Unidos, Alemania, Italia
Norwegian University of Science and Technology
St. Olavs Hospital

Terminado

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Carcinoma de pulmón de células no pequeñas

Noruega
Eli Lilly and Company

Terminado

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Cáncer de pulmón de células no pequeñas metastásico | Neoplasia de pulmón de células no pequeñas no escamosas | Cáncer de pulmón de células no pequeñas en estadio IIIB

Reino Unido, Suecia
The First Affiliated Hospital with Nanjing Medical...

Desconocido

Quimioterapia combinada con o sin anlotinib en el tratamiento de mantenimiento del cáncer de pulmón de células no pequeñas no escamosas.

Cáncer de pulmón no microcítico no escamoso
Ain Shams University

Desconocido

Cuatro frente a seis ciclos de pemetrexed/platino para MPM

Mesotelioma pleural maligno

Egipto
Spanish Lung Cancer Group

Terminado

Estudio de pemetrexed más cisplatino como tratamiento de primera línea en pacientes con CPNM no escamoso avanzado (Phalcis)

Carcinoma De Pulmón De Células No Pequeñas

España

A Study for Patients With Head and Neck Cancer

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

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Inscripción (Actual)

Fase

Contactos y Ubicaciones

Ubicaciones de estudio

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Descripción

Plan de estudios

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo

Intervención / Tratamiento

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Medidas de resultado secundarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Colaboradores e Investigadores

Patrocinador

Fechas de registro del estudio

Fechas importantes del estudio

Inicio del estudio

Finalización primaria (Actual)

Finalización del estudio (Actual)

Fechas de registro del estudio

Enviado por primera vez

Primero enviado que cumplió con los criterios de control de calidad

Publicado por primera vez (Estimar)

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

Última actualización enviada que cumplió con los criterios de control de calidad

Última verificación

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Ensayos clínicos sobre pemetrexed

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Iran

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones