Phase I Study of Nab-Paclitaxel and Gemcitabine with Proton Therapy for Locally Advanced Pancreatic Cancer

Sponsor: University of Maryland, Baltimore

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03652428

Provider View

This clinical trial is testing the safety and best dose of combining two chemotherapy drugs, nab-paclitaxel and gemcitabine, with proton therapy for treating locally advanced pancreatic cancer. Participants will receive proton therapy five days a week for three weeks, along with chemotherapy once a week.

Patient Parameters

Program Overview

The study aims to find the safest and most effective dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when used with proton therapy for treating locally advanced pancreatic cancer. Proton therapy will be given once a day, Monday through Friday, for three weeks. Chemotherapy will be administered on each Monday during these weeks. The goal is to see if this combination can effectively target the tumor while minimizing side effects.

Description

This trial is designed to determine the maximum safe dose and recommended dose for future studies of nab-paclitaxel and gemcitabine combined with proton therapy for pancreatic cancer. Proton therapy will be delivered at a fixed dose over 15 sessions, five days a week. Unlike previous studies that used photon radiation, this study uses proton therapy to focus more precisely on the tumor, potentially reducing side effects. The high-dose radiation will avoid areas close to sensitive organs like the stomach and intestines. This approach is based on previous research that suggests it can increase safety while maintaining effectiveness. Nab-paclitaxel is known to enhance the effects of radiation, which is why careful dose management is important.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pancreatic adenocarcinoma.
  • Cancer that has not spread to distant organs or lymph nodes.
  • Imaging results showing the tumor cannot be surgically removed due to its location.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood cell counts and kidney function as indicated by specific tests.
  • Total bilirubin level of 2 mg/dL or less.

Exclusion Criteria

  • Cancer that can be surgically removed or is borderline resectable.
  • Previous surgery to remove pancreatic cancer.
  • Previous radiation therapy to the abdomen that overlaps with the study treatment area.
  • Previous chemotherapy, except for specific regimens like FOLFIRINOX or Gem-Abrax.
  • Severe side effects from prior chemotherapy.
  • More than two dose reductions during prior chemotherapy.
  • Use of certain medications that affect liver enzymes, which must be stopped 14 days before starting the study.
  • Significant nerve damage or specific genetic conditions affecting drug metabolism.
  • Pregnant or breastfeeding women.
  • HIV-positive patients on antiretroviral therapy due to potential drug interactions.
  • Non-compliance with previous chemotherapy treatments.

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