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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. února 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

101

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: gemcitabin hydrochlorid
Vzhledem k tomu, IV
Lék: karboplatina
Vzhledem k tomu, IV
Lék: cediranib maleát
Podáno ústně
Aktivní komparátor: 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.
Lék: gemcitabin hydrochlorid
Vzhledem k tomu, IV
Lék: karboplatina
Vzhledem k tomu, IV

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alliance for Clinical Trials in Oncology

Spolupracovníci

National Cancer Institute (NCI)

Vyšetřovatelé

  • Studijní židle: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2007

Primární dokončení (Aktuální)

1. dubna 2009

Dokončení studie (Aktuální)

1. února 2010

Termíny zápisu do studia

První předloženo

16. května 2006

První předloženo, které splnilo kritéria kontroly kvality

16. května 2006

První zveřejněno (Odhad)

17. května 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. března 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. února 2017

Naposledy ověřeno

1. února 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Zdravotní podmínky

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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