Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients
Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone.
Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients.
A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC)|
- Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients. [ Time Frame: Efficacy after the inclusion of the last patient ] [ Designated as safety issue: Yes ]
- Overall Survival Quality of life [ Time Frame: After the follow up period ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)
Patients will receive Pemetrexed intravenous infusion (i.v.) via infusion pump or gravity drip, at a dose of 500 mg/m2 (over a target of 10 minutes). Pemetrexed should be administered every 21 days on the same day.
Patients will receive carboplatin intravenous continuous infusion (i.v.) over 30 minutes via infusion pump or gravity drip, at a dose of AUC5. Carboplatin should be administered every 21 days on the same day.
Active Comparator: Gemcitabine
Gemcitabine 1250 mg/mq
Patients will receive gemcitabine 1250 mg/m2 as a 30 minutes intravenous infusion on days 1 and 8 and of a 21-day cycle.Patients may continue to receive gemcitabine for up to a maximum of 6 cycles.
|Contact: Armando Santoro, MD||+39028224 ext firstname.lastname@example.org|
|Contact: Raffaele Cavina, MD||+39028224 ext email@example.com|
|Istituto Clinco Humanitas||Recruiting|
|Rozzano, Milan, Italy, 20089|
|Contact: Armando Santoro, MD +39028224 ext 4080 firstname.lastname@example.org|
|Contact: Raffaele Cavina, MD +39028224 ext 4588 email@example.com|
|Sub-Investigator: Raffaele Cavina, MD|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|