A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
This is a phase I clinical trial examining the safety, feasibility, and toxicity of
gemcitabine and erlotinib when given in combination with capecitabine in adult patients with
locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine
once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by
mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on
days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated
dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have
been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose
will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended
phase II dose (RPTD) to confirm tolerability at that dose.
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles
or until disease progression and patients may continue on the study regimen unless they
experience an adverse event that meets the criteria for a dose limiting toxicity.
Phase:
Phase 1
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute