Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer
1 other identifier
interventional
46
1 country
1
Brief Summary
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated. STUDY OBJECTIVES Primary: Objective response rate Secondary: Progression free survival, Overall survival and Safety of Tarceva
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedApril 27, 2007
April 1, 2007
April 25, 2007
April 25, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
Secondary Outcomes (3)
Progression free survival
Overall survival
Safety of Tarceva
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years.
- Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
- Measurable disease.
- 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).
You may not qualify if:
- Female patients who are pregnant or lactating.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grupo Gallego de Cancer de Pulmon
Santiago de Compostela, A CORUÑA, 15701, Spain
Related Publications (1)
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.
PMID: 24352251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joquin Casal, MD
GGCP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
January 1, 2006
Last Updated
April 27, 2007
Record last verified: 2007-04