36
Participants
Start Date
July 31, 2006
Primary Completion Date
December 31, 2010
Study Completion Date
December 31, 2010
Gemcitabine
"The starting dose of gemcitabine will be 400 mg/m2 on day 1 of a two-week cycle.~Gemcitabine is given on day 1 every two weeks according to the dose escalation schedule below:~Dose level -1 200mg/m2 Dose level 1 400mg/m2 Dose level 2 600mg/m2 Dose level 3 800mg/m2 Dose level 4 1000mg/m2 Dose level 5 1000mg/m2 It is administered as an intravenous infusion, the lyophilized powder being diluted in normal saline, at a fixed dose of 10 mg/m2/minute."
Oxaliplatin
Oxaliplatin is given by intravenous infusion on day 2 every 2 weeks according to the dose escalation schedule below: Dose level -1 - 4 85mg/m2 Dose level 5 100mg/m2 Oxaliplatin should be diluted in 250 to 500 ml of 5% glucose solution to give a concentration not less than 0.2 mg/ml. It must be infused via a central venous line or peripheral vein over 2 hours. In the event of extravasation, administration must be discontinued immediately and the extravasation managed according to local procedures.
Imatinib
"Imatinib is given for 7 days every cycle starting 2 days before the gemcitabine is given, including administration on days 1 and 2 when gemcitabine and oxaliplatin are given, and for 3 days afterwards (i.e. days -2 to +5). It is thus given on a 7 days on and 7 days off intermittent dosing schedule. The dose will be fixed at 400 mg daily in tablet form and taken once daily with food.~Imatinib should commence either in the morning or lunchtime of day -2 and be taken at the same time daily for seven consecutive days in total."
Royal Marsden NHS Foundation Trust, Sutton
Royal Marsden NHS Foundation Trust
OTHER