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

NCT ID: NCT01048320

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Advanced Pancreatic Cancer

Keywords

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pancreatic cancer toxicity chemotherapy dose finding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Gemcitabine plus Oxaliplatin in combination with imatinib mesylate

Group Type OTHER

Gemcitabine

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Marsden NHS Foundation Trust

Principal Investigators

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David Cunningham

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCT No: 2005-004022-99

Identifier Type: -

Identifier Source: secondary_id

CCR2731

Identifier Type: -

Identifier Source: org_study_id