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A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Pancreatic Cancer

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Trial Information

A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CCR2731

NCT ID:

NCT01048320

Start Date:

July 2006

Completion Date:

December 2010

Related Keywords:

  • Advanced Pancreatic Cancer
  • pancreatic cancer
  • toxicity
  • chemotherapy
  • dose finding
  • Pancreatic Neoplasms

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