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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 februari 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

101

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: gemcitabine hydrochloride
IV gegeven
Geneesmiddel: carboplatine
IV gegeven
Geneesmiddel: cediranib maleaat
Mondeling gegeven
Actieve vergelijker: 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.
Geneesmiddel: gemcitabine hydrochloride
IV gegeven
Geneesmiddel: carboplatine
IV gegeven

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2007

Primaire voltooiing (Werkelijk)

1 april 2009

Studie voltooiing (Werkelijk)

1 februari 2010

Studieregistratiedata

Eerst ingediend

16 mei 2006

Eerst ingediend dat voldeed aan de QC-criteria

16 mei 2006

Eerst geplaatst (Schatting)

17 mei 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

16 februari 2017

Laatst geverifieerd

1 februari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren