Combining radiation and nab-paclitaxel for advanced pancreatic cancer
A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
This study is testing whether combining a special cancer drug called nab-paclitaxel with higher doses of radiation can help people with advanced pancreatic cancer live longer and better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | radiation, Chemotherapy |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT02207465 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of combining nab-paclitaxel with dose-escalated radiation therapy in patients with unresectable and borderline resectable pancreatic cancer. The study aims to improve local control and survival rates by intensifying local therapy. Initially, the trial will focus on determining the maximum tolerated dose (MTD) of nab-paclitaxel while maintaining a standard radiation dose, followed by evaluating the addition of paricalcitol. The approach leverages nab-paclitaxel's unique properties to enhance the efficacy of radiation treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically confirmed adenocarcinoma of the pancreas that is either unresectable or borderline resectable.
Not a fit: Patients with resectable pancreatic cancer or those with other types of pancreatic tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival and local control for patients with advanced pancreatic cancer.
How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in enhancing treatment outcomes for pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the pancreas. * Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014): Unresectable * Greater than 180 degrees of SMA encasement * Any celiac abutment * Unreconstructible SMV/portal occlusion * Aortic invasion or encasement * Nodal metastases beyond the field of resection Borderline resectable * Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen * Encasement of the SMV/portal vein but without encasement of the nearby arteries * Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting. * Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis * Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall * Age \> 18 years. * ECOG performance status of ≤ 1. * Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST \< 5 times the upper limit of normal. * Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial. * Patients must be able to provide written informed consent. Exclusion Criteria: * Distant metastatic disease. * Prior history of abdominal radiation therapy. * Prior systemic therapy for pancreatic cancer. * Prior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer). In-situ carcinoma is allowed. * Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. * Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study. * Pregnant women, women planning to become pregnant and women that are nursing
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Chester County Hospital — West Chester, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Edgar Ben-Josef, MD — Abramson Cancer Center at Penn Medicine
- Study coordinator: Edgar Ben-Josef, MD
- Email: Edgar.Ben-Josef@pennmedicine.upenn.edu
- Phone: 215-662-6567
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.