RecruitingPhase 1NCT04158635

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

A Phase 1 Study of Gemcitabine, Nab-Paclitaxel, and Bosentan in Patients With Unresectable Pancreatic Cancer


Sponsor

City of Hope Medical Center

Enrollment

21 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called bosentan (typically used for pulmonary arterial hypertension) to standard chemotherapy can improve outcomes for patients with pancreatic cancer that cannot be surgically removed. Bosentan blocks a protein pathway that tumors use to protect themselves from chemotherapy, potentially making the cancer more vulnerable to treatment. **You may be eligible if...** - You are an adult with unresectable (inoperable) pancreatic cancer - You are a candidate for gemcitabine plus nab-paclitaxel, or mFOLFIRINOX chemotherapy - You weigh at least 40 kg - Your blood counts, kidney, and liver function are within acceptable ranges - You are willing to provide a tumor tissue sample (archival or fresh biopsy if safe) **You may NOT be eligible if...** - You have previously received chemotherapy for metastatic pancreatic cancer - Your liver or kidney function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBosentan

Given PO

DRUGGemcitabine

Given IV

DRUGNab-paclitaxel

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04158635


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