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GDC-0449 and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer

2014-07-24 14:01:00 | BioPortfolio

Summary

RATIONALE: GDC-0449 may slow the growth of tumor cells. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GDC-0449 together with chemotherapy may kill more tumor cells.

PURPOSE: This clinical trial is studying giving GDC-0449 together with gemcitabine hydrochloride in treating patients with advanced pancreatic cancer.

Description

OBJECTIVES:

Primary

- To evaluate the number and percentage of pancreatic cancer stem cells before and after treatment with Hedgehog antagonist GDC-0449 in patients with advanced pancreatic cancer.

- To assess the effect of treatment with Hedgehog antagonist alone and in combination with gemcitabine hydrochloride on total circulating tumor cell numbers.

Secondary

- To assess progression-free survival at 3 months after treatment with Hedgehog antagonist GDC-0449 and gemcitabine hydrochloride.

- To assess response rate to treatment and overall survival of patients with advanced pancreatic cancer treated with Hedgehog antagonist GDC-0449 alone and in combination with gemcitabine hydrochloride.

- To evaluate the toxicity of GDC-0449 alone and in combination with gemcitabine hydrochloride.

OUTLINE: Patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo core-needle biopsy at baseline and on day 21 of treatment with Hedgehog antagonist GDC-0449 and blood samples are collected on days 0, 15, and 43 for correlative studies.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

Hedgehog antagonist GDC-0449, gemcitabine hydrochloride, laboratory biomarker analysis, needle biopsy

Location

University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
United States
48109-0942

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:00-0400

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Medical and Biotech [MESH] Definitions

A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

A frizzled-like, G-protein-coupled receptor that associates with PATCHED RECEPTORS to transduce signals from HEDGEHOG PROTEINS and initiate hedgehog signaling to ZINC FINGER PROTEIN GLI1. It may normally inhibit signaling in the absence of SONIC HEDGEHOG PROTEIN binding to PATCHED RECEPTOR-1.

A benzamide derivative that is used as a dopamine antagonist.

A family of intercellular signaling proteins that play and important role in regulating the development of many TISSUES and organs. Their name derives from the observation of a hedgehog-like appearance in DROSOPHILA embryos with genetic mutations that block their action.

A phenylethylamine derivative that acts as a calcium antagonist showing hemodynamic effects in patients with acute myocardial infarction.

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