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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00816868 |
Because of the effect in the treatment of NSCLC, the capecitabine and erlotinib may compose to a new regimen for NSCLC. Based on the preclinical observation and the confirmed clinical synergistic anti-tumor activity of combined capecitabine and erlotinib in gemzar refractory APC[13], we previously conducted a phase II study of erlotinib in combination with capecitabine against NSCLC.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: erlotinib in combination with capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Erlotinib in Combination With Capecitabine as First-Line Treatment in Elderly Patients With Stage IIIB/IV Adenocarcinoma Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 60 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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non-small cell lung cancer (NSCLC): Experimental
erlotinib in combination with capecitabine as first-line treatment in elderly patients with stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC)
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Drug: erlotinib in combination with capecitabine
Erlotinib 150 mg Q.D. orally for 21 days plus Capecitabine 1000 mg/m2 twice daily for 2 weeks followed by 1 week break every 21 days Until PD, unacceptable toxicity or death.
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Li Zhang, MD | 86-20-87343458 | zhangli6@mail.sysu.edu.cn |
Study Chair: | Li Zhang, MD | Cancer Center of Sun Yat-Sen University (CCSU) |
Responsible Party: | Cancer Center of Sun Yat-sen University ( Cancer Center of Sun Yat-sen University ) |
Study ID Numbers: | C-TONG 0807 |
Study First Received: | January 2, 2009 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00816868 |
Health Authority: | China: State Food and Drug Administration |
stage IIIB/IV adenocarcinoma non-small cell lung cancer |
Erlotinib Thoracic Neoplasms Capecitabine Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |