Combination treatment for advanced pancreatic cancer
A Phase 1 Study of Gemcitabine, Nab-Paclitaxel, and Bosentan in Patients With Unresectable Pancreatic Cancer
This study is testing a new combination of medications for people with advanced pancreatic cancer to see if it can help slow tumor growth and improve their quality of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT04158635 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and effectiveness of combining bosentan with gemcitabine and nab-paclitaxel for patients with unresectable pancreatic cancer. The study aims to determine the optimal dosage of bosentan and assess its impact on tumor growth and patient outcomes. Participants will receive these medications over a specified treatment cycle, and various assessments will be conducted to evaluate response rates, progression-free survival, and overall survival. Additionally, the study will explore the pharmacokinetics of the drugs and their effects on quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults with unresectable pancreatic carcinoma who are eligible for specific chemotherapy regimens.
Not a fit: Patients currently using contraindicated medications or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced pancreatic cancer.
How similar studies have performed: Other studies have shown promise with similar chemotherapy combinations, but the addition of bosentan is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Ravi Salgia — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.