Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01195415
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date June 2010
Completion date October 10, 2014

See also
  Status Clinical Trial Phase
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT02005315 - A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer Phase 1
Completed NCT01453153 - Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer Phase 1/Phase 2
Completed NCT01064622 - Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer Phase 1/Phase 2
Completed NCT00095966 - Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT02178436 - Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01647828 - A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer Phase 1/Phase 2
Terminated NCT01555489 - Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca Phase 2
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Completed NCT01232829 - Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer Phase 2
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00735917 - Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer Phase 2
Completed NCT02896907 - Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery Early Phase 1
Completed NCT02307539 - Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer N/A
Completed NCT02050178 - Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer Phase 1
Completed NCT01488552 - Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT01222689 - Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT00397787 - Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine Phase 2
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1