Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and gemcitabine hydrochloride may kill more tumor cells.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To obtain tumor biopsies before and after therapy with GDC-0449 (vismodegib) to evaluate the effect of inhibition of hedgehog signaling on pancreatic cancer stem cells by: evaluating the tumor for number and percentage of pancreatic cancer stem cells before and after treatment with GDC-0449. SECONDARY OBJECTIVES: I. To assess progression free survival (PFS) at 3 months following treatment with GDC-0449 and gemcitabine (gemcitabine hydrochloride). II. To assess response rate to treatment and overall survival in patients with advanced pancreas cancer treated with GDC-0449 alone and in combination with gemcitabine. III. To evaluate the toxicity of GDC-0449 alone and in combination with gemcitabine. OUTLINE: Patients receive vismodegib orally (PO) once daily (QD) on days 1-28 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS [3 weeks]. Median, percentage of CD44+/ CD24+/ ESA+ cells (Full Range). Baseline Median % of CD44+/CD24+/ESA+ CSCs: Treatment (Vismodegib, Gemcitabine Hydrochloride) (n=22): 4.79 (0.43 to 37.2). 3 Weeks Post Tx Median % of CD44+/CD24+/ESA+ CSCs: Treatment (Vismodegib, Gemcitabine Hydrochloride) (n=22): 3.09 (0.74 to 45.9).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

The Number of Participants With an Objective Best Response (CR + PR) [Up to 4 weeks]. Number, participants. Treatment (Vismodegib, Gemcitabine Hydrochloride) (n=25): 5.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Progression Free Survival [Up to 24 months]. Median, months (95% Confidence Interval). Treatment (Vismodegib, Gemcitabine Hydrochloride) (n=25): 2.8 (1.4 to 4.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0 [Up to 4 weeks]. Number, percentage of patients. Treatment (Vismodegib, Gemcitabine Hydrochloride) (n=25): 56.