MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00401492|
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : July 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: gemcitabine prolonged continuous infusion Drug: cisplatin Drug: vinorelbine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||April 2007|
- Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
- Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine
- patient quality of life
- the prognostic significance of the ADL and IADL scales for time to progression and survival
- exploratory predictive clinical variables for chemotherapy related toxicity
- exploratory predictive clinical variables for response to chemotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401492
|Principal Investigator:||Cesare Gridelli, M.D.||San Giuseppe Moscati Hospital|
|Principal Investigator:||Francesco Perrone, M.D.||National Cancer Institute, Naples Italy|