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Sponsored by: |
Chinese Society of Lung Cancer |
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Information provided by: | Chinese Society of Lung Cancer |
ClinicalTrials.gov Identifier: | NCT00891579 |
This study is a prospective trial of Alimta versus IRESSA among EGFR(-) Non Small Cell Lung Cancer (NSCLC) patients in a 2nd line setting.
Condition | Intervention | Phase |
---|---|---|
Non Small Cell Lung Cancer |
Drug: pemetrexed (Alimta) Drug: Gefitinib (IRESSA) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 2 Randomized, Controlled, Open-Label Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without EGFR Mutations |
Estimated Enrollment: | 150 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Treatment of Alimta
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Drug: pemetrexed (Alimta)
treatment of single pemetrexed with vitamin supplement until discontinued conditions are met
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2: Active Comparator |
Drug: Gefitinib (IRESSA)
treatment of Gefitinib will be applied until discontinued conditions are met
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have previously received one platinum-based chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred within six months since the finishing of neoadjuvant or adjuvant chemotherapy.
Adequate organ function including the following:
Previous palliative radiation therapy is allowed, but limited in LESS 25% of the bone marrow and must not have included whole pelvis radiation.
Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed one month before study entry. Radiotherapy should not be administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented.
For women:
For men:
Exclusion Criteria:
China | |
Beijing Cancer Hospital | Active, not recruiting |
Beijing, China | |
Shanghai Chest Hospital | Not yet recruiting |
Shanghai, China | |
Shanghai Pulmonary Hospital | Not yet recruiting |
Shanghai, China | |
Sun Yat-sen University Cancer Center | Not yet recruiting |
Guangzhou, China | |
China, Guangdong | |
Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital | Recruiting |
Guangzhou, Guangdong, China, 510080 | |
Contact: Huang Yu juan, MD 8620-83827812 ext 50810 W.HYJ123@163.COM |
Responsible Party: | Guangdong General hospital ( Wu Yilong /Director of Chinese Society of Lung Cancer/Chief of Lung Cancer Research Institute & Cancer Center/Vice President of Guangdong Provincial People's Hospital ) |
Study ID Numbers: | C-TONG0806 |
Study First Received: | April 30, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00891579 History of Changes |
Health Authority: | China: Guangdong Provincial General Hospital |
NSCLC EGFR Pemetrexed Gefitinib without EGFR mutations |
Antimetabolites Thoracic Neoplasms Folic Acid Antagonists Protein Kinase Inhibitors Carcinoma Pemetrexed Folic Acid Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Vitamins Non-small Cell Lung Cancer Mitogens Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |