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Sponsors and Collaborators: |
National University Hospital, Singapore Eli Lilly and Company |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00212043 |
Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
Condition | Intervention | Phase |
---|---|---|
Non Small Cell Lung Cancer |
Drug: carboplatin and gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-Small Cell Carcinoma |
Estimated Enrollment: | 74 |
Study Start Date: | July 2000 |
Estimated Study Completion Date: | February 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Histologically or cytologically confirmed NSCLC.
WBC count > 3500/microl Neutrophils > 2000/microl Platelet count > 100,000/microl Hemoglobin > 9 g/dl (transfusion allowed)
Serum creatinine < 133 micromol/l, or Creatinine clearance > 30 ml/min, based on the Cockcroft formula (see section 5.1.1)
Bilirubin < 1.5 x upper limit of normal ALT/AST < 2 x upper limit of normal if liver metastases are absent < 5 x upper limit of normal if liver metastases are present
Exclusion Criteria:
• Patients with only evaluable disease.
Study ID Numbers: | CTRG L08/99 |
Study First Received: | September 13, 2005 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00212043 History of Changes |
Health Authority: | Singapore: Health Sciences Authority |
randomised phase II trial gemcitabine and carboplatin |
Thoracic Neoplasms Antimetabolites Immunologic Factors Carboplatin Antiviral Agents Immunosuppressive Agents Carcinoma Radiation-Sensitizing Agents |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |