Actively Recruiting
A Phase 1 Study of Gemcitabine, Nab-Paclitaxel, and Bosentan in Patients With Unresectable Pancreatic Cancer
Led by City of Hope Medical Center · Updated on 2026-04-17
21
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of bosentan with chemotherapy drugs gemcitabine and nab-paclitaxel for treating pancreatic cancer that cannot be removed by surgery. This phase I trial aims to study the side effects, best dose, and how well this combination works compared to chemotherapy alone. The goal is to improve treatment outcomes for patients with unresectable pancreatic cancer by blocking hormones that may promote tumor growth and spread. Participants receive bosentan orally twice daily on specific days during each 21-day treatment cycle. Alongside bosentan, patients are given nab-paclitaxel and gemcitabine intravenously on days 1, 8, and 15. Treatment cycles repeat every 21 days unless the cancer progresses or side effects become unacceptable. Different dosing schedules of bosentan are tested during the first cycle, followed by continuous dosing in later cycles. During the study, participants undergo safety and toxicity assessments, response evaluations, and quality of life questionnaires. Researchers monitor adverse events, treatment compliance, survival outcomes, and disease progression. After treatment ends, patients have follow-up visits at 30 days, then every two months if disease is stable, and every six months after progression. The total study duration varies depending on individual outcomes and ongoing assessments.
CONDITIONS
Brief Title
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with unresectable pancreatic carcinoma
- Candidates for gemcitabine plus nab-paclitaxel chemotherapy every 2 weeks or mFOLFIRINOX every 2 weeks
- Willing to allow use of existing tumor tissue or undergo a fresh biopsy if safe
- Weight at least 40 kg
- Absolute neutrophil count (ANC) of at least 1500/mm3 and platelets of at least 100,000/mm3
- Liver enzymes AST and ALT no more than 1.5 times upper normal limit; up to 3 times if liver metastases
- Total serum bilirubin no more than 1.5 times upper normal limit
- Creatinine clearance of at least 60 mL/min
You will not qualify if you...
- Current or planned use of Warfarin, Cyclosporine A, Rifampicin, or Glyburide
- Use of agents contraindicated with strong CYP3A4 inducers
- Use of strong inhibitors or inducers of CYP2C9 or CYP3A
- Use of agents that moderately inhibit both CYP2C9 and CYP3A
- Prior malignancies except certain treated skin, cervical, or early stage cancers in remission
- Current or history of grade 2 or higher peripheral neuropathy
- Known allergy to eggs or any components of the study drugs or their excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 28-day cycles until disease progression or unacceptable toxicity
Participants receive bosentan orally twice daily on specified days of each 28-day cycle along with nab-paclitaxel and gemcitabine intravenously on days 1, 8, and 15. Cycles repeat every 28 days unless disease progresses or unacceptable toxicity occurs.
3 visits per cycle (in-person) for drug administration and assessments
Duration - Up to 2 years
After treatment completion, participants are followed up at 30 days, then every 2 months if no disease progression, and biannually after progression.
Visits every 2 months initially, then biannual visits depending on disease progression
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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