A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer

• Status: Suspended
• Trial end date: 2025-12-01

Summary

The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer. The investigators propose to do this by combining nab-paclitaxel concurrently with dose-escalated radiation therapy. In the first part of this phase I study (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held constant at a standardly accepted level. The use of this novel chemoradiotherapy regimen will take advantage of nab-paclitaxels specific anti-tumor and anti-stromal properties, which may enhance the efficacy of radiation therapy, and thereby improve local control. After the MTD of nab-paclitaxel had been determined, in the second part of this study (sub-trial 2), the investigators will administer nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation. The investigators will utilize a combination of protons and IMRT to safely deliver high doses of radiation while maximally sparing surrounding normal tissue. Patients will also preferentially have 2-3 fiducial markers placed in or around the tumor for daily localization and will be treated at breath hold in order to prevent tumor movement with normal respiration. Such a technique will help minimize target volumes and thereby avoid critical normal structures. The investigators will use gemcitabine and nab-paclitaxel before and after chemoradiotherapy given its promising results in metastatic pancreatic cancer patients. Correlative tissue and serum biomarkers are an important, but optional, part of this study.

• Phase: Phase 1

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel