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Sponsored by: |
National Cancer Institute, Naples |
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Information provided by: | National Cancer Institute, Naples |
ClinicalTrials.gov Identifier: | NCT00401492 |
The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: gemcitabine prolonged continuous infusion Drug: cisplatin Drug: vinorelbine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-Small Cell Lung Cancer Elderly Patients |
Estimated Enrollment: | 210 |
Study Start Date: | June 2002 |
The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases.
Arm A: gemcitabine:
Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 & 8 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm B: cisplatin + vinorelbine:
Vinorelbine 25 mg/m² on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm C: cisplatin + gemcitabine:
Gemcitabine 1000 mg/m2,, on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Cesare Gridelli, M.D. | San Giuseppe Moscati Hospital |
Principal Investigator: | Francesco Perrone, M.D. | National Cancer Institute, Naples Italy |
Study ID Numbers: | MILES-02 |
Study First Received: | November 17, 2006 |
Last Updated: | December 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00401492 History of Changes |
Health Authority: | Italy: Ethics Committee |
elderly chemotherapy quality of life ADL toxicity |
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Immunologic Factors Quality of Life Immunosuppressive Agents Antiviral Agents Carcinoma Vinorelbine Respiratory Tract Diseases |
Cisplatin Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents Lung Diseases Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |