Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Advanced Pancreatic Cancer
Interventions
DRUG

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."

DRUG

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.

DRUG

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."

Trial Locations (1)

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Royal Marsden NHS Foundation Trust

OTHER

NCT01048320 - Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer | Biotech Hunter | Biotech Hunter