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

Royal Marsden NHS Foundation Trust

Status and phase: Completed; Phase 1

Conditions: Advanced Pancreatic Cancer

Treatments: Drug: Oxaliplatin; Drug: Imatinib; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01048320

EudraCT No: 2005-004022-99

CCR2731

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment

Other group

Description:

Gemcitabine plus Oxaliplatin in combination with imatinib mesylate

Treatment:

Drug: Oxaliplatin

Drug: Imatinib

Drug: Gemcitabine