- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00063258
Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer
5 april 2016 uppdaterad av: M.D. Anderson Cancer Center
Phase II Randomized Open-Label Trial of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Tarceva™) in Combination With Paclitaxel and Carboplatin Prior to Surgery in Resectable Stage IIIA (N2) and IIIB (T4 N2) NSCLC: A Clinical Outcome and Biological Endpoint Trial
The goal of this clinical research study is to learn about the safety and effectiveness of OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery in the treatment of non-small cell lung cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a phase II, single institution open label randomized trial of induction carboplatin and paclitaxel plus/minus daily oral OSI-774 in patients with potentially resectable NSCLC that is stage IIIA and IIIB (T4 satellite nodules or invasion into T4 structures but no malignant effusion.)
N3 disease is excluded.
Patients will be required to have pathologically demonstrated N2 disease via mediastinoscopy.
Forty patients will be treated with 3 courses of chemotherapy followed by surgery.
Ten of these patients will be randomized to chemotherapy alone and 30 patients to chemotherapy plus OSI-774.
The 10 patients will serve as a chemotherapy alone control for molecular endpoint analysis.
OSI-774 will be stopped the night before surgery.
At the time of surgery, pathologic response will be determined.
Following surgery, patients will be treated with consolidation radiation therapy if there are positive margins or N2 lymph nodes at the time of resection.
Patients who have no N2 disease at surgery will have the option of consolidation radiation therapy but will not be required to have it done.
Patients not able to tolerate radiation even if they have N2 disease or positive margins at surgery may continue on this study.
This will be followed by maintenance OSI-774 for patients from both arms of the study.
OSI-774 will be continued as maintenance to a maximum of 2 years following surgery.
Tissue for molecular studies will be obtained pretreatment either at the time of diagnostic biopsy or mediastinoscopy.
Post-treatment tissue will be obtained at the time of surgery.
This tissue will be assayed for defined molecular endpoints using immunohistochemistry, immunoprecipitation and mRNA expression analysis.
Blood, urine, hair follicles, and skin samples will also be collected from patients who consent to provide these.
Studietyp
Interventionell
Inskrivning (Faktisk)
5
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- MD Anderson Cancer Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Must have signed consent for LAB03-0383
- Pathologic documentation of NSCLC
- Stage IIIA and IIIB (T4 satellite nodules or invasion into T4 structures but no malignant effusion) with all patients requiring mediastinoscopy positive N2, potentially resectable disease. N3 disease is excluded.
- Measurable disease
- Zubrod performance status of 0 or 1
- Calculated post-resectional FEV1 of > 40%
- WBC>4000/l, ANC>1500/l, platelets > 100,000/l
- Serum creatinine < 1.5 ULN or calculated creatinine > 50 cc/min
- Total serum bilirubin <1.5 x ULN or SGPT or SGOT < 2 X ULN
- The following must be completed within 28 days of registration: CT scan of the chest and upper abdomen to include the adrenals. Mediastinoscopy to document ipsilateral nodal involvement and exclude N3 disease Blood tests, and pulmonary function tests The following must be completed within 2 months of registration: Pet scan If a CT PET is done more than 28 days, only the CT needs to be repeated and a bone scan to rule out bone metastases
Exclusion Criteria:
- No prior chemotherapy or radiation for NSCLC
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least five years. If patient is suspected or known to have basal or squamous skin cancer, this maybe treated after induction chemotherapy is completed at the time of thoracotomy.
- No post-obstructive pneumonia or other serious infection or other serious underlying medical condition that would impair ability of patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor.
- Pregnant or nursing women may not participate
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Chemotherapy + Tarceva
|
150 mg/day, starting day 1 and stopping night prior to surgery.
Andra namn:
Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.
Andra namn:
Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.
|
Aktiv komparator: Chemotherapy Alone
|
Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.
Andra namn:
Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Patients With Response
Tidsram: 5 Years to collect outcome information
|
Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.
|
5 Years to collect outcome information
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ralph Zinner, MD, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2003
Primärt slutförande (Faktisk)
1 april 2008
Avslutad studie (Faktisk)
1 april 2008
Studieregistreringsdatum
Först inskickad
24 juni 2003
Först inskickad som uppfyllde QC-kriterierna
24 juni 2003
Första postat (Uppskatta)
25 juni 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 april 2016
Senast verifierad
1 april 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Proteinkinashämmare
- Karboplatin
- Paklitaxel
- Erlotinib hydroklorid
Andra studie-ID-nummer
- ID02-327
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 .
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