39
Participants
Start Date
March 31, 2008
Primary Completion Date
September 30, 2015
Study Completion Date
September 30, 2016
Paclitaxel
"* 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"
Gemcitabine
"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"
Avastin
"* 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."
University of Alabama at Birmingham, Birmingham
Collaborators (1)
Genentech, Inc.
INDUSTRY
University of Alabama at Birmingham
OTHER