At a glance
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Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Gemcitabine, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 39 participants across 1 site.
Detailed Summary
This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined markers that predict for clinical benefit to Avastin. Preliminary studies show that there are several observations that support the concept of metronomic chemotherapy with or without the combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown to enhance the clinical endpoints of the study (response rate and progressive-free survival). Proof of metronomic scheduling requires the development of appropriate intermediate surrogate markers. Several markers will be assessed.
Study Details
Timeline
Interventions
* Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion: * Dexamethasone 20mg, intravenously (IV) * Diphenhydramine 50 mg IV * Ranitidine 50 mg IV * Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion. * The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15) Paclitaxel Dose Levels: * Dose Level 1 \_\_\_\_\_\_\_\_80 mg/m2/weekly * Dose Level -1 \_\_\_\_\_\_\_\_70 mg/m2/weekly
Premedication * Prophylactic antiemetics: 5-HT3-receptor antagonist prior to infusion with gemcitabine. * Prior to receiving paclitaxel chemotherapy * Gemcitabine will be given at the initial dose of 200mg/m2/week (Dose Level 1) for 3 out of 4 weeks (Day 1, 8, 15), as a 30 minute (IV) infusion. * The dose of gemcitabine can be escalated to 300mg/m2/weekly (Dose Level 2) after the first cycle of treatment if no significant toxicity is experienced. Gemcitabine Dose Levels: * Dose Level 2 \_\_\_\_\_\_\_\_300 mg/m2/weekly * Dose Level 1 \_\_\_\_\_\_\_\_200 mg/m2/weekly * Dose Level -1 \_\_\_\_\_\_\_\_150 mg/m2/weekly
* The dose of Avastin is 10 mg/kg IV every 2 weeks * It will be administered following the administration of chemotherapy * The first infusion will be administered over 90 minutes; if well tolerated, the second and subsequent doses will be administered as a 60-minute and 30-minute infusion, respectively. * It should not be administered or mixed with dextrose solutions.