Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer (RPGOG1)
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|ClinicalTrials.gov Identifier: NCT01048320|
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : September 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic Cancer||Drug: Gemcitabine Drug: Oxaliplatin Drug: Imatinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
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 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 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.
- The primary outcome measure for the study is to establish the Maximum Tolerated Dose of the drug regimen based on the endpoint of dose-limiting toxicity [ Time Frame: 1 year ]
- Progression free survival
- Overall survival
- Response rate for those with measurable disease
- Characterise safety profile of Gemcitabine Plus Oxaliplatin in Combination with imatinib mesylate (Glivec) in Patients with Gemcitabine-Refractory Advanced Adenocarcinoma of the Pancreas
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048320
|Royal Marsden NHS Foundation Trust|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||David Cunningham||Royal Marsden NHS Foundation Trust|