A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
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. This combination of
drugs has never been used before.
Screening tests will consists of demographics, a medical history, and physical exam, vital
signs, height, weight, performance status, blood counts, chemistries, and clotting. There
will also be an electrocardiogram (EKG), tumor measurement (computed tomography [CT Scan] or
magnetic resonance imaging [MRI] or positron emission tomography CT [PET-CT]), cancer
antigen (CA 19-9), and a serum pregnancy test (for women of childbearing potential). Tumor
measurements are also performed after cycle 2, 4, and 6 (study end).
Treatment will be administered on an outpatient basis and consists of both intravenous (IV)
medication and tablets taken by mouth. The gemcitabine will be administered at Moffitt once
per week for 3 weeks, followed by a week off treatment. One tablet of erlotinib will be
taken by mouth continuously starting with day one of cycle 1 while capecitabine will be
taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest
period. This set of treatments is called a cycle. One full cycle of treatment will last 28
days and a total of 6 cycles of treatments are planned. Before each cycle we will repeat the
blood counts and a brief physical exam (vital signs) will be recorded weekly during the
first 3 weeks of the 28 day cycle of treatment (when receiving Gemcitabine).
An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Patients
will be enrolled at the lowest dosage level, if no patients have unacceptable toxicity, the
dose will be escalated and additional patients enrolled. If one of the patients at a given
dose level experiences a dose limiting toxicity (DLT), more patients will be treated at that
dose level. When 2 patients have DLTs at the same dose, the dose will be deescalated to the
previous dose and additional patients will be enrolled. After de-escalation begins, 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. Patients may continue on the study regimen unless they
experience an adverse event that meets the criteria for a dose limiting toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
The Maximum-tolerated dose (of capecitabine) is determined as the dose level at which two or more of six patients experience dose-limiting toxicity. The MTD will not exceed 1250 mg/m2.
Within 4 months of Cycle 1 Day 1 (C1D1)
Gregory Springett, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|