City of Hope Medical Center
This phase I trial studies the side effects and best dose of bosentan and how well it works when given together with gemcitabine and nab-paclitaxel for the treatment of pancreatic cancer that cannot be removed by surgery (unresectable). Bosentan may block the hormone endothelin and prevent the growth and spread of pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bosentan with chemotherapy (gemcitabine and nab-paclitaxel) may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
PRIMARY OBJECTIVE: I. To assess the safety, toxicity and feasibility of administering bosentan with nab-paclitaxel and gemcitabine. SECONDARY OBJECTIVES: I. To assess the response rate associated with this combination therapy in first line pancreatic cancer patients. II. To assess the progression-free survival and overall survival of all patients who start protocol therapy, and describe the outcomes based on measures of compliance during the lead-in week, and compliance with supplement during chemotherapy. EXPLORATORY OBJECTIVES: I. To determine the impact of bosentan on the mass transpo…
Main Inclusion Criteria * Adult patients with unresectable pancreatic carcinoma * Patients must be a candidate to receive one of the following chemotherapy combinations as determined by the treating physician: Arm A2: gemcitabine plus nab-paclitaxel given every 2 weeks (arm A1 is closed per this amendment) Arm B: mFOLFIRINOX given every 2 weeks * Willingness to permit study team to obtain and use archival tissue, if already existing, or, be willing to undergo a fresh tumor biopsy if clinically possible (exceptions may be provided by study PI if medically unsafe to perform biopsy). * Weight…
Given PO
Given IV
Given IV
Ancillary studies
Ancillary studies
Arctuva estimate
Verify or correct the compensation shown for this listing.