Pancreatic Cancer Clinical Trial
Official title:
Phase I/II Study of LDE225 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Locally Advanced or Metastasized Pancreatic Cancer
The 5 year survival of patients with locally advanced or metastatic pancreatic cancer is less
than 5 %. Since the introduction of gemcitabine, further advances in therapy in the
advanced/metastatic setting have been extremely slow. Numerous phase III studies have
evaluated different gemcitabine-based regimens as first-line therapy, but in most cases, any
observed benefits have been small and restricted to patients with a good performance status
(PS). Recently two new chemotherapy combination schedules, FOLFIRINOX and Gemcitabine +
nab-paclitaxel demonstrated a significant survival improvement compared to gemcitabine alone.
Nab-paclitaxel is especially interesting because it is able to break-down the tumor matrix
and increases the concentration of cytotoxic drugs in the tumor.
Our study will explore the modification of the desmoplastic reaction seen in pancreatic
cancer using two approaches, targeting tumor stroma by nab-paclitaxel and the hedgehog
inhibitor LDE225 and targeting the tumor cells with gemcitabine and nab-paclitaxel.
Growing body of evidence suggests that the stroma is not only a mechanical barrier that may
prevent efficient delivery of various anticancer therapies to the tumor, but also constitutes
a dynamic compartment of pancreatic tumors that is critically involved in tumor formation,
progression and metastasis. Thus, targeting both tumor stroma and cancer cells could be a
lucrative strategy to increase the efficacy of our therapeutic approach.
In the present study we want to explore the safety and activity of the chemotherapy
combination: Gemcitabine + nab-paclitaxel + LDE225. LDE225 is a hedgehog inhibitor with
promising antitumor activity in several cancer models, including pancreatic cancer. One of
the main activities is also the degradation of the tumor matrix.
Patients with locally advanced or metastatic pancreatic cancer will be treated with fixed
doses of gemcitabine + nab-paclitaxel, the same doses used in the recently presented phase
III study (von Hoff American Society of Clinical Oncology ASCO 2013). In the phase I part of
the study LDE225 will be added according to standard dose escalation strategy for phase I
studies, and at the maximum tolerated dose (MTD) patients will be treated in the phase II
part of the study.
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