Gemcitabine And Oxaliplatin (Gem-Ox) Plus Glivec In Gemcitabine-refractory Pancreatic Cancer

Study Overview

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

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.

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.

Advanced Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Oxaliplatin
DRUG: Imatinib

CCR2731
EudraCT No: 2005-004022-99

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-01-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-09-21
First Submitted that Met QC Criteria 2010-01-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-09-25
First Posted (ESTIMATED) 2010-01-13	Results First Posted N/A	Last Verified 2012-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Treatment Gemcitabine plus Oxaliplatin in combination with imatinib mesylate	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 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 concentrat 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

Participant Group/Arm

Intervention/Treatment

OTHER: Treatment

Gemcitabine plus Oxaliplatin in combination with imatinib mesylate

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

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 concentrat

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

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: David Cunningham, Royal Marsden NHS Foundation Trust

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record