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

Phase 1

Completed

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Imatinib

• Registration Number: NCT01048320
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

The main research objective is to work out the optimal doses of the novel combination of gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine.

Detailed Description

Using the phase I study design, the dose of gemcitabine will be escalated in several steps to identify the highest tolerable dose that can be given safely. Based on pre-defined dose-limiting toxicity, the maximum tolerated dose of the combination will be identified and a safer dose for further evaluation of this regimen in pancreatic cancer selected. The primary objectives are therefore based around safety of the drug combination.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• age > 18 years
• gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment)
• locally advanced or metastatic disease with measurable or non-measurable disease
• life expectancy of greater than 10 weeks
• prior treatment with investigational therapies including EGFR and VEGF antagonists is allowed when administered>4 weeks prior to start of therapy

Exclusion Criteria

• any serious uncontrolled medical condition
• prior radiation treatment is not allowed
• no prior chemotherapy within the previous 4 weeks
• known peripheral neuropathy > CTCAE v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible
• known brain metastases
• lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication
• fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception
• pregnancy or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Oxaliplatin	Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
Treatment	Gemcitabine	Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
Treatment	Imatinib	Gemcitabine plus Oxaliplatin in combination with imatinib mesylate

Primary Outcome Measures

Name	Time	Method
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	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom