Clinical trial NCT01048320: Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Pancreatic Cancer
Keywords: pancreatic cancer
toxicity
chemotherapy
dose finding
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: 1 year
Secondary outcomes:
measure: Progression free survival
measure: Overall survival
measure: Response rate for those with measurable disease
measure: Characterise safety profile of Gemcitabine Plus Oxaliplatin in Combination with imatinib mesylate (Glivec) in Patients with Gemcitabine-Refractory Advanced Adenocarcinoma of the Pancreas
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References: