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Sponsors and Collaborators: |
Genentech Hoffmann-La Roche |
Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00453362 |
This is a single-arm, open-label, multicenter, international pilot study to evaluate the relationship between FDG- and FLT-PET responses and clinical outcome in recurrent or refractory NSCLC patients receiving erlotinib. The study will enroll approximately 100 patients at approximately 4 sites in Australia and 4 sites in the United States.
Condition | Intervention | Phase |
Non-Small Cell Lung Cancer |
Other: 3'-deoxy-3'-[18F]fluorothymidine (FLT) Other: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) Drug: erlotinib HCl |
Phase I Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Erlotinib Erlotinib hydrochloride Dextrose |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib |
Estimated Enrollment: | 100 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2010 |
Arms | Assigned Interventions |
1: Experimental |
Other: 3'-deoxy-3'-[18F]fluorothymidine (FLT)
IV repeating dose
Other: 2-deoxy-2-[18F]fluoro-D-glucose (FDG)
IV repeating dose
Drug: erlotinib HCl
Oral repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Morgan Lam | lam.morgan@gene.com |
United States, California | |||||
Hem Onc Med Grp Orange Cty | Recruiting | ||||
Orange, California, United States, 92868 | |||||
Contact: Maria Gonzalez 714-771-8000 ext 7816 maria1.gonzalez@stjoe.org | |||||
Pacific Cancer Medical Center | Recruiting | ||||
Anaheim, California, United States, 92801 | |||||
Contact: Elizabeth Garcia 714-999-1465 ext 230 elizabethg@pacificcancer.com | |||||
USC/Norris Comp Cancer Center | Recruiting | ||||
Los Angeles, California, United States, 90033 | |||||
Contact: Gina Tse 323-865-0514 tse_g@ccnt.usc.edu | |||||
Wilshire Oncology Medical Group | Recruiting | ||||
Corona, California, United States, 92879 | |||||
Contact: Debbie Malouf 909-596-5333 ext 227 malouf.debbie@womgi.com |
Genentech |
Hoffmann-La Roche |
Study Director: | Andrea Pirzkall, M.D. | Genentech |
Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Roche Products Pty Limited ([Roche Australia]) 
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Responsible Party: | Genentech, Inc. ( Andrea Pirzkall, M.D., Study Director ) |
Study ID Numbers: | OSI3926g, ML20773 |
First Received: | March 26, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00453362 |
Health Authority: | United States: Food and Drug Administration |
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