Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
13 de setembro de 2012 atualizado por: Eli Lilly and Company
Randomized Phase III Study of Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer After Platinum-Based Therapy
This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy.
Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice.
Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab & Pemetrexed or Pemetrexed alone; Cetuximab & Docetaxel or Docetaxel alone).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
939
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 4N2
- 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.
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
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Quebec
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Montreal, Quebec, Canadá, H2L 4M1
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Sainte-Foy, Quebec, Canadá, G1V 4G2
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St-Jerome, Quebec, Canadá, J7Z 5T3
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
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Montgomery, Alabama, Estados Unidos, 36106
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Arizona
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Phoenix, Arizona, Estados Unidos, 85012
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Tucson, Arizona, Estados Unidos, 85715
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Tuscon, Arizona, Estados Unidos, 85704
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California
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Greenbrae, California, Estados Unidos, 94904
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La Jolla, California, Estados Unidos, 92093
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Colorado
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Denver, Colorado, Estados Unidos, 80218
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Connecticut
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Stamford, Connecticut, Estados Unidos, 06902
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Trumbull, Connecticut, Estados Unidos, 06611
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Florida
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Jacksonville, Florida, Estados Unidos, 32256
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Lake Worth, Florida, Estados Unidos, 33461
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West Palm Beach, Florida, Estados Unidos, 33401
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Georgia
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Athens, Georgia, Estados Unidos, 30607
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Atlanta, Georgia, Estados Unidos, 30341
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Augusta, Georgia, Estados Unidos, 30901
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Illinois
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Chicago, Illinois, Estados Unidos, 60674
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46227
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Kansas
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Overland Park, Kansas, Estados Unidos, 66210
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Wichita, Kansas, Estados Unidos, 67214
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817
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Frederick, Maryland, Estados Unidos, 21701
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Michigan
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Kalamazoo, Michigan, Estados Unidos, 49048
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Mount Clemens, Michigan, Estados Unidos, 48043
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- 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.
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St Louis Park, Minnesota, Estados Unidos, 55416
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Missouri
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St Joseph, Missouri, Estados Unidos, 64507
- 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.
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Montana
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Billings, Montana, Estados Unidos, 59101
- 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.
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89169
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New Jersey
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Cherry Hill, New Jersey, Estados Unidos, 08003
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New York
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Albany, New York, Estados Unidos, 12208
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Rochester, New York, Estados Unidos, 14623
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North Carolina
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Cary, North Carolina, Estados Unidos, 27518
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Concord, North Carolina, Estados Unidos, 28025
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High Point, North Carolina, Estados Unidos, 27262
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267
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Columbus, Ohio, Estados Unidos, 43215
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- 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.
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Portland, Oregon, Estados Unidos, 97239
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Pennsylvania
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Dunmore, Pennsylvania, Estados Unidos, 18512
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Kingston, Pennsylvania, Estados Unidos, 18704
- 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.
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Philadelphia, Pennsylvania, Estados Unidos, 19114
- 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.
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- 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.
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Hilton Head Island, South Carolina, Estados Unidos, 29926
- 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.
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Mt. Pleasant, South Carolina, Estados Unidos, 29464
- 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.
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38138
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Texas
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Bedford, Texas, Estados Unidos, 76022
- 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.
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Dallas, Texas, Estados Unidos, 75246
- 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.
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Grapevine, Texas, Estados Unidos, 76051
- 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.
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Houston, Texas, Estados Unidos, 77030
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Mesquite, Texas, Estados Unidos, 75150
- 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.
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Sugar Land, Texas, Estados Unidos, 77479
- 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.
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Tyler, Texas, Estados Unidos, 75702
- 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.
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Utah
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Salt Lake City, Utah, Estados Unidos, 84106
- 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.
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Vermont
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Colchester, Vermont, Estados Unidos, 05446
- 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.
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- 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.
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Richmond, Virginia, Estados Unidos, 23249
- 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.
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Washington
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Seattle, Washington, Estados Unidos, 98133
- 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.
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Vancouver, Washington, Estados Unidos, 98684
- 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.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Pathologic confirmation of metastatic, unresectable, or locally-advanced NSCLC.
- Disease progression during or following one prior platinum-based chemotherapy regimen for advanced disease (stage IIIB or IV).
- Bidimensionally measurable disease.
- Karnofsky performance status score of 60 to 100 at study entry.
- The participant has tumor tissue available for immunohistochemical determination of epidermal growth factor (EGFR) expression.
- Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent, or prior radiation therapy (palliative radiation therapy is allowed).
- Accessible for treatment and follow-up. Participants enrolled in this trial must be treated at the participating center.
- Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception.
- WOCBP must have a negative serum or urine pregnancy test.
Exclusion Criteria:
- Women who are pregnant or breastfeeding.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy.
- Symptomatic or uncontrolled metastases in the brain. Participants receiving a glucocorticoid for brain metastases will be excluded, but those receiving anticonvulsants will be eligible.
- Uncontrolled pleural effusion or ascites.
- Peripheral neuropathy greater than grade 2, as assessed by the National Cancer Institutes-Common Toxicity Criteria Adverse Events (NCI-CTCAE), Version 3.0.
- Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy, but without evidence of disease for greater than or equal 3 years will be allowed to enter the trial.
- More than one prior chemotherapy regimen for advanced disease.
- Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm3, a platelet count <100,000/mm3, and a hemoglobin level <9 g/dL. Red blood cell transfusions are not permitted within 7 days of receiving cetuximab, docetaxel, or pemetrexed.
- Inadequate hepatic function, defined by a total bilirubin level >1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) levels >2.5 times the ULN (greater than or equal to 5 times the ULN if known liver metastases), and an alkaline phosphatase level >5.0 times the ULN.
- Inadequate renal function defined by a serum creatinine level >1.5 times the ULN.
- Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Participants must not have received prior chimerized or murine monoclonal antibody therapy. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted >30 days prior to randomization.
- Prior treatment with docetaxel or pemetrexed therapy.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- Inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents such as piroxicam). Aspirin will be permitted during the study.
- Patients (including prisoners) who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Prior treatment with an experimental drug or medical device within 30 days of randomization.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Docetaxel
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Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
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Comparador Ativo: Pemetrexede
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Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
Outros nomes:
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Experimental: Cetuximab & Pemetrexed
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Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
Outros nomes:
Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.
Outros nomes:
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Experimental: Cetuximab & Docetaxel
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Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.
Outros nomes:
Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Progression Free Survival (PFS)
Prazo: Randomization to progression of disease or death due to any cause up to 59.6 months
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PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause.
Participants who were alive and without progression were censored at the date of their last tumor assessment.
PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab & Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab & Docetaxel versus Docetaxel).
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Randomization to progression of disease or death due to any cause up to 59.6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: Randomization to the date of death from any cause up to 72.8 months
|
OS was defined as the time from randomization to death.
Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.
|
Randomization to the date of death from any cause up to 72.8 months
|
|
Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])
Prazo: Randomization until progression of disease or death from any cause up to 59.6 months
|
The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines.
It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm.
Participants with no post-baseline evaluation were considered as non-responders.
The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.
|
Randomization until progression of disease or death from any cause up to 59.6 months
|
|
Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)
Prazo: Randomization to progression of disease or death due to any cause up to 59.6 months
|
The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines.
It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm.
The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.
|
Randomization to progression of disease or death due to any cause up to 59.6 months
|
|
Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)
Prazo: At baseline, every 3 weeks and 30 days after end of therapy up to 50 months
|
The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms.
Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much).
Scores range from 0-28 and higher score indicates fewer symptoms.
Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not >5 weeks apart for participants, whose baseline LCS score was ≤26.
Symptom response rate was the percentage of participants with symptomatic response.
|
At baseline, every 3 weeks and 30 days after end of therapy up to 50 months
|
|
Time to Symptomatic Progression
Prazo: Randomization until symptomatic progression up to 48.3 months
|
The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms.
Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and <5 weeks, apart.
The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline.
Time to symptomatic progression = the time from randomization to the symptom progression date.
For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment.
|
Randomization until symptomatic progression up to 48.3 months
|
|
Duration of Overall Response (OR)
Prazo: Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months
|
The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death.
Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment.
The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group.
|
Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months
|
|
Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities
Prazo: Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)
|
National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities.
Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0.
Participants reported had grade 3 or 4 toxicities (or both potentially).
Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 AEs: life-threatening consequences; urgent intervention indicated.
|
Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2005
Conclusão Primária (Real)
1 de julho de 2011
Conclusão do estudo (Real)
1 de julho de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
1 de novembro de 2004
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de novembro de 2004
Primeira postagem (Estimativa)
2 de novembro de 2004
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
15 de outubro de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de setembro de 2012
Última verificação
1 de setembro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Imunológicos
- Antagonistas do ácido fólico
- Docetaxel
- Pemetrexede
- Cetuximabe
Outros números de identificação do estudo
- 13423
- I4E-MC-JXBC (Outro identificador: Eli Lilly and Company)
- CP02-0452 (Outro identificador: ImClone)
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