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Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer (RPGOG1)

Primary Purpose

Advanced Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Gemcitabine
Oxaliplatin
Imatinib
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer focused on measuring pancreatic cancer, toxicity, chemotherapy, dose finding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Gemcitabine plus Oxaliplatin in combination with imatinib mesylate

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2010
Last Updated
September 21, 2012
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01048320
Brief Title
Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer
Acronym
RPGOG1
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer
Keywords
pancreatic cancer, toxicity, chemotherapy, dose finding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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
Intervention Name(s)
Oxaliplatin
Intervention Description
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
Intervention Name(s)
Imatinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Progression free survival
Title
Overall survival
Title
Response rate for those with measurable disease
Title
Characterise safety profile of Gemcitabine Plus Oxaliplatin in Combination with imatinib mesylate (Glivec) in Patients with Gemcitabine-Refractory Advanced Adenocarcinoma of the Pancreas

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cunningham
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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