Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00466284
Last Updated: 2007-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
46 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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STUDY OBJECTIVES
Primary: Objective response rate
Secondary: Progression free survival, Overall survival and Safety of Tarceva
Detailed Description
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Expected total enrollment: 46
Study start: January, 2006
Study completation: January, 2008
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Tarceva (erlotinib)
Eligibility Criteria
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Inclusion Criteria
* Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
* Measurable disease.
* Written informed consent must be obtained prior to the inclusion into the trial.
* Karnofsky performance status of 80%.
* Patients must have been treated with no prior chemotherapy or radioterapy.
* Patients must have adequate bone marrow, liver and renal function.
* Bone Marrow: WBC \> 3000 x 103/mm3,
* Platelets \> 100 x 103/mm3,
* Hgb \> 10.0 gm/dl,
* ANC \>1500 x 103/mm3,
* Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal,
* Renal:Creatinine \< 1.5 mg/dl (132 µmol/l).
Exclusion Criteria
* Patients who have used other investigational agents within 21 days prior to study entry.
* Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
* Significant comorbidity.
18 Years
90 Years
ALL
No
Sponsors
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Grupo Gallego de Cancer de Pulmon
OTHER
Principal Investigators
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Joquin Casal, MD
Role: PRINCIPAL_INVESTIGATOR
GGCP
Locations
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Grupo Gallego de Cancer de Pulmon
Santiago de Compostela, A CORUÑA, Spain
Countries
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Central Contacts
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Facility Contacts
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Joaquin Casal, MD
Role: primary
References
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Casal Rubio J, Firvida-Perez JL, Lazaro-Quintela M, Baron-Duarte FJ, Alonso-Jaudenes G, Santome L, Afonso-Afonso FJ, Amenedo M, Huidobro G, Campos-Balea B, Lopez-Vazquez MD, Vazquez S. A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study. Cancer Chemother Pharmacol. 2014 Mar;73(3):451-7. doi: 10.1007/s00280-013-2370-z. Epub 2013 Dec 19.
Other Identifiers
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GGCP023/05-ML19497
Identifier Type: -
Identifier Source: org_study_id