Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of New Mexico Genentech |
---|---|
Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00391586 |
Primary Objective:To compare the activities of erlotinib to that of platinum-based therapy in NSCLC
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | INST 0601C: A Randomized Phase II Protocol of Erlotinib Versus Standard Platinum-Based Chemotherapy in Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung |
Estimated Enrollment: | 300 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Primary Objective:To compare the activities(the progression-free survival, and the incidence and severity of toxicities, and reversibility of toxicities) of erlotinib to that of platinum-based therapy in NSCLC
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Baseline laboratory values (bone marrow, renal, hepatic):
Adequate bone marrow function:
Renal function:
Hepatic function:
Other Eligibility Criteria:
Exclusion Criteria:
Contact: Dennis V Jones, MD | 505 272-5837 | dvjones@salud. unm.edu |
Contact: Ian Rabinowitz, MD | 505 272-5837 | irabinowitz@salud.unm.edu |
United States, New Mexico | |
University of New Mexico | Recruiting |
Albuquerque, New Mexico, United States, 87131 | |
Contact: Leanne Gideon 505-272-5688 lgideon@salud.unm.edu | |
Principal Investigator: Dennie V Jones, MD |
Principal Investigator: | Dennie V Jones, MD | University of New Mexico |
Responsible Party: | University of New Mexico CRTC ( Dennie Jones, MD ) |
Study ID Numbers: | INST 0601C |
Study First Received: | October 23, 2006 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00391586 History of Changes |
Health Authority: | United States: Institutional Review Board |
erlotinib NSCLC chemotherapy |
platinum lung lung cancer |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |