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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.
- 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.
- 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.
Allocation: Non-Randomized, Primary Purpose: Treatment
Hedgehog antagonist GDC-0449, gemcitabine hydrochloride, laboratory biomarker analysis, needle biopsy
University of Michigan Comprehensive Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:01:00-0400
RATIONALE: Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...
RATIONALE: 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 div...
RATIONALE: GDC-0449 may be effective in treating young patients with medulloblastoma. PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating young ...
RATIONALE: GDC-0449 and RO4929097 may slow the growth of tumor cells and may be an effective treatment for advanced breast cancer. PURPOSE: This phase I trial is studying the side effects...
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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.
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