Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer

Launched by CITY OF HOPE MEDICAL CENTER · Nov 7, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with pancreatic cancer that cannot be surgically removed. The study is testing a combination of three treatments: gemcitabine, nab-paclitaxel, and bosentan. Gemcitabine and nab-paclitaxel are chemotherapy drugs that help kill cancer cells or stop them from growing, while bosentan may help block a hormone that can contribute to cancer growth. The goal is to find the best dose of bosentan and to see if this combination works better than chemotherapy alone.

To participate in the trial, patients need to be adults with unresectable pancreatic cancer and should be eligible for specific chemotherapy combinations. They should also be willing to provide a tissue sample or have a biopsy if needed. Participants can expect to receive these treatments every two weeks and will be closely monitored for any side effects. It's important to note that certain medications and health conditions may prevent someone from joining the study. If you or a loved one is considering participation, discussing it with a healthcare provider can help determine eligibility and suitability.

Gender

ALL

Eligibility criteria

• • 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 ≥ 40 kg
• • ANC ≥ 1500/mm3; platelets ≥ 100,000/mm3
• • AST, ALT ≤ 1.5 x ULN. Patients with liver metastases ≤ 3 x ULN
• • Total serum bilirubin ≤ 1.5 x ULN
• • Creatinine clearence ≥ 60 mL/min
• • Main Exclusion Criteria
• • Current or planned use of Warfarin, Cyclosporine A, Rifampicin, Glyburide (other diabetic medications are allowed)
• • Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
• • Strong inhibitors or inducers of CYP2C9
• • Strong inhibitors or inducers of CYP3A
• • Agent or agents that moderately inhibit both CYP2C9 and CYP3A (via a single concomitant agent, or co-administration of concomitant agents)
• • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
• • Current or history of ≥ Grade 2 peripheral neuropathy
• • Known allergy to eggs or any of the components within the study agents and/or their excipients.