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Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

16 de fevereiro de 2017 atualizado por: Alliance for Clinical Trials in Oncology

A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin together with AZD2171 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

OBJECTIVES:

Primary

  • Assess the objective tumor response rate in patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride, carboplatin, and AZD2171 as first-line therapy.

Secondary

  • Compare the proportion of patients who are progression-free at 6 months after treatment with gemcitabine hydrochloride and carboplatin with vs without AZD2171.
  • Compare the duration of response for responding patients treated with these regimens.
  • Compare the time-to-progression and time-to-treatment failure.
  • Compare the 1-year overall survival.
  • Compare the clinical toxicities.
  • Assess the safety and tolerability of these regimens in these patients.

Tertiary

  • Collect blood and tumor specimens for future evaluation of pharmacogenetic and proteomic markers of tumor response and toxicity to therapy with these agents.
  • Bank paraffin-embedded tissue blocks/slides and blood samples for future histochemistry evaluation and DNA extraction.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacologic correlative studies.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.

Tipo de estudo

Intervencional

Inscrição (Real)

101

Estágio

  • Fase 2

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

  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259-5499
        • Mayo Clinic Scottsdale
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora, Illinois, Estados Unidos, 60504
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, Estados Unidos, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Estados Unidos, 61520
        • Graham Hospital
      • Carthage, Illinois, Estados Unidos, 62321
        • Memorial Hospital
      • Eureka, Illinois, Estados Unidos, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Estados Unidos, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Estados Unidos, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, Estados Unidos, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Estados Unidos, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, Estados Unidos, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Macomb, Illinois, Estados Unidos, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, Estados Unidos, 61265
      • Moline, Illinois, Estados Unidos, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Normal, Illinois, Estados Unidos, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Estados Unidos, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Estados Unidos, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Estados Unidos, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Estados Unidos, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Estados Unidos, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Estados Unidos, 61614
        • Proctor Hospital
      • Peoria, Illinois, Estados Unidos, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Estados Unidos, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Estados Unidos, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Estados Unidos, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Estados Unidos, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Estados Unidos, 61362
        • St. Margaret's Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, Estados Unidos, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, Estados Unidos, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Estados Unidos, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, Estados Unidos, 46360
        • Saint Anthony Memorial Health Centers
      • South Bend, Indiana, Estados Unidos, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Estados Unidos, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Estados Unidos, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, Estados Unidos, 46617
        • South Bend Clinic
    • Iowa
      • Bettendorf, Iowa, Estados Unidos, 52722
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Cedar Rapids Oncology Associates
      • Des Moines, Iowa, Estados Unidos, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Estados Unidos, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Estados Unidos, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Estados Unidos, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Estados Unidos, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Estados Unidos, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines, Iowa, Estados Unidos, 50307
        • Mercy Capitol Hospital
      • Mason City, Iowa, Estados Unidos, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Sioux City, Iowa, Estados Unidos, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Estados Unidos, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Estados Unidos, 51104
        • Mercy Medical Center - Sioux City
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Estados Unidos, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, Estados Unidos, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, Estados Unidos, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Estados Unidos, 48503
        • Hurley Medical Center
      • Flint, Michigan, Estados Unidos, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Estados Unidos, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Holland, Michigan, Estados Unidos, 49423
        • Holland Community Hospital
      • Iron Mountain, Michigan, Estados Unidos, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Estados Unidos, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Estados Unidos, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Estados Unidos, 48154
        • St. Mary Mercy Hospital
      • Muskegon, Michigan, Estados Unidos, 49442
        • Hackley Hospital
      • Pontiac, Michigan, Estados Unidos, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Estados Unidos, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, Estados Unidos, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • St. Joseph, Michigan, Estados Unidos, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
      • Warren, Michigan, Estados Unidos, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, Estados Unidos, 49519
        • Metro Health Hospital
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
        • MeritCare Bemidji
      • Burnsville, Minnesota, Estados Unidos, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Estados Unidos, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Estados Unidos, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Estados Unidos, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, Estados Unidos, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, Estados Unidos, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Estados Unidos, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Estados Unidos, 55350
        • Hutchinson Area Health Care
      • Lichfield, Minnesota, Estados Unidos, 55355
        • Meeker County Memorial Hospital
      • Mankato, Minnesota, Estados Unidos, 56002
        • Immanuel St. Joseph's
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, Estados Unidos, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Estados Unidos, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, Estados Unidos, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • United Hospital
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • HealthEast Cancer Care at St. Joseph's Hospital
      • Shakopee, Minnesota, Estados Unidos, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • St. Paul, Minnesota, Estados Unidos, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, Estados Unidos, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Estados Unidos, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
      • Woodbury, Minnesota, Estados Unidos, 55125
        • HealthEast Cancer Care at Woodwinds Health Campus
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, Estados Unidos, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care and Research
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Estados Unidos, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, Estados Unidos, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Estados Unidos, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Estados Unidos, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, Estados Unidos, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Estados Unidos, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Estados Unidos, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Estados Unidos, 59405
      • Havre, Montana, Estados Unidos, 59501
        • Northern Montana Hospital
      • Helena, Montana, Estados Unidos, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Estados Unidos, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Estados Unidos, 59801
        • Community Medical Center
      • Missoula, Montana, Estados Unidos, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Estados Unidos, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Estados Unidos, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Estados Unidos, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Estados Unidos, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, Estados Unidos, 68131-2197
        • Creighton University Medical Center
    • New York
      • Buffalo, New York, Estados Unidos, 14263-0001
        • Roswell Park Cancer Institute
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Estados Unidos, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Estados Unidos, 58122
        • MeritCare Broadway
      • Grand Forks, North Dakota, Estados Unidos, 58201
        • Altru Cancer Center at Altru Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Danville, Pennsylvania, Estados Unidos, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hazleton, Pennsylvania, Estados Unidos, 18201
        • Geisinger Hazleton Cancer Center
      • State College, Pennsylvania, Estados Unidos, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, Estados Unidos, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wilkes-Barre, Pennsylvania, Estados Unidos, 18765
        • Mercy Hospital at Wilkes-Barre
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Estados Unidos, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Estados Unidos, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Estados Unidos, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Franciscan Skemp Healthcare - La Crosse Campus
      • Marinette, Wisconsin, Estados Unidos, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, Estados Unidos, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, Estados Unidos, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Sheridan, Wyoming, Estados Unidos, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Squamous cell histology allowed
    • No mixed histology with small cell component

  • Stage IIIB (with pleural effusion) or stage IV disease

    • Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed

  • Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan

    • If the only site of measurable disease was previously irradiated, progressive disease must be evident
  • Ineligible for bevacizumab therapy

  • No symptomatic, untreated, or uncontrolled CNS metastases

    • CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement)
  • Alkaline phosphatase ≤ 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No proteinuria ≥ 1+
  • No uncontrolled blood pressure (BP), defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg in spite of adequate antihypertensive therapy
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection)
  • No seizure disorder
  • No significant traumatic injury within 4 weeks prior to study entry

  • No second primary malignancy except any of the following:

    • Carcinoma in situ of the cervix
    • Nonmelanoma skin cancer
    • Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
    • History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed < 5 years prior to registration
    • Treated stage I breast cancer ≤ 5 years prior to registration

  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • Significant pulmonary symptoms at baseline due to disease
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
    • Baseline hemoptysis
    • Cavitating lesions
  • No QTc prolongation > 500 msec or other significant ECG abnormality within the past 14 days
  • No New York Heart Association class III or IV disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior chemotherapy for advanced lung cancer

    • Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed
  • More than 12 months since prior immunotherapy and biologic therapy
  • More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
  • At least 2 weeks since prior WBRT
  • No radiotherapy to ≥ 25% of bone marrow

  • No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery)

    • Insertion of a vascular access device not considered major or minor surgery
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent grapefruit or grapefruit juice during AZD2171 treatment
  • No concurrent drugs or biologics with proarrhythmic potential
  • Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)

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
Experimental: Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Medicamento: cloridrato de gemcitabina
Dado IV
Medicamento: carboplatina
Dado IV
Medicamento: maleato de cediranibe
Dado oralmente
Comparador Ativo: Arm II
Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Medicamento: cloridrato de gemcitabina
Dado IV
Medicamento: carboplatina
Dado IV

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
Prazo: Up to 5 years

A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

  • Complete Response (CR): disappearance of all target lesions;
  • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions
Up to 5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
Prazo: 6 months

Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
6 months
Progression-free Survival (Phase II Patients Only)
Prazo: Up to 5 years
Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.
Up to 5 years
Time to Treatment Failure (Phase II Patients Only)
Prazo: Up to 15 months
Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.
Up to 15 months
Overall Survival at 1 Year After Randomization (Phase II Patients Only)
Prazo: 1 year
Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.
1 year
Overall Survival (Phase II Patients Only)
Prazo: Up to 5 years
Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.
Up to 5 years
Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)
Prazo: Cycle 1 (up to 3 weeks)
DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.
Cycle 1 (up to 3 weeks)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Alliance for Clinical Trials in Oncology

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Cadeira de estudo: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 junho de 2007

Conclusão Primária (Real)

1 de abril de 2009

Conclusão do estudo (Real)

1 de fevereiro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

16 de maio de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de maio de 2006

Primeira postagem (Estimativa)

17 de maio de 2006

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de março de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de fevereiro de 2017

Última verificação

1 de fevereiro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCCTG-N0528
  • NCI-2012-02694 (Identificador de registro: CTRP (Clinical Trials Reporting System))
  • CDR0000468945 (Identificador de registro: PDQ (Physician Data Query))

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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