- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00182806
Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine.
Secondary
- Determine the median time to progression in patients treated with this regimen.
OUTLINE: This a non-randomized, open-label, multicenter study.
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 month and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263-0001
- Roswell Park Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
Stage IIIA or IIIB disease
- Progressive disease
Stage IV disease
- Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy
Measurable or evaluable disease, as defined by 1 of the following criteria:
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- Lesions apparent on CT scan that do not meet the criterion for measurability
- Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST and ALT ≤ 1.5 times normal
- Alkaline phosphatase < 1.5 times normal
- Bilirubin ≤ 1.3 mg/dL
Renal
- Creatinine ≤ 1.6 mg/dL OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past 3 months
- No life-threatening ventricular arrhythmia requiring maintenance therapy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- No uncontrolled seizure disorder
- No uncontrolled diabetes mellitus
- No active infection requiring systemic therapy
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other unstable or serious condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy
- Prior irinotecan allowed
- No prior gemcitabine
- No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 1 month since prior participation in another clinical trial using an investigational agent
- No other concurrent investigational agents
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Objective response (complete, partial, and stable disease)
|
Sekundära resultatmått
Resultatmått |
---|
Mediantid till progression
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nithya Ramnath, MD, Roswell Park Cancer Institute
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Topoisomerasinhibitorer
- Topoisomeras I-hämmare
- Gemcitabin
- Irinotekan
Andra studie-ID-nummer
- CDR0000441226
- RPCI-I-31204
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Lungcancer
-
Chang Gung Memorial HospitalAvslutad
-
University of ZurichDeep Breath Intelligence (DBI)RekryteringLung-/luftvägssjukdomarSchweiz
-
424 General Military HospitalAvslutad
-
Celularity IncorporatedAvslutadSteg 2 Lung sarkoidos | Steg 3 Lung sarkoidosFörenta staterna
-
Centre Hospitalier Universitaire, AmiensAvslutadHemodialyskomplikation | Lung ultraljudFrankrike
-
Tuberculosis Research Centre, IndiaInternational Union Against Tuberculosis and Lung Diseases; Sarvodaya Charitable... och andra samarbetspartnersAktiv, inte rekryterandePre-extensivt läkemedelsresistent lung-TB | Behandling Intolerant multiresistent lung-TB | Icke-responsiv multiresistent lung-TBIndien
-
Pontificia Universidad Catolica de ChileRekryteringLung ultraljud | Öppen bukkirurgiChile
-
Papa Giovanni XXIII HospitalAvslutadLungtransplantation | Ex Vivo Lung PerfusionItalien
-
University of Colorado, DenverChildren's Hospital Colorado; Food and Drug Administration (FDA)AvslutadHypertoni;Lung;PrimärFörenta staterna
-
University Hospital, LilleAvslutad
Kliniska prövningar på gemcitabine hydrochloride
-
M.D. Anderson Cancer CenterIndragenMetastaserande icke-småcelligt lungkarcinom | Steg IVA lungcancer AJCC v8 | Steg IVB lungcancer AJCC v8 | Steg IV lungcancer AJCC v8
-
Sierra Oncology LLC - a GSK companyAvslutadAvancerade solida tumörerSpanien, Storbritannien
-
University of Erlangen-Nürnberg Medical SchoolAvslutadBukspottskörtelcancerTyskland
-
AstraZenecaRekryteringGallvägscancerFrankrike, Spanien, Italien, Korea, Republiken av, Japan, Tyskland, Förenta staterna, Singapore
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekrytering
-
Shenzhen University General HospitalHar inte rekryterat ännu
-
Kansai Hepatobiliary Oncology GroupAvslutad
-
3D Medicines (Sichuan) Co., Ltd.Har inte rekryterat ännuNeoplasmer i gallvägarna
-
Samsung Medical CenterAvslutadBukspottskörtelcancerKorea, Republiken av
-
3D Medicines (Sichuan) Co., Ltd.RekryteringNeoplasmer i gallvägarnaKina