Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer
RenovoRx
Summary
The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.
Description
All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as SBRT radiation therapy for approximately a total of four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16-week treatment course until disease progression at the discretion of the Investigat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 8 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 2 2. Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the start of cycle 1) 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0…
Interventions
- DrugGemcitabine
Chemotherapy
- Drugnab-paclitaxel
Chemotherapy
- DeviceRenovoCath
Intra-arterial catheter
Locations (42)
- VA Loma Linda Healthcare SystemLoma Linda, California
- Sutter Cancer Center SacramentoSacramento, California
- Rocky Mountain Cancer CentersDenver, Colorado
- Comprehensive Cancer Care and Research Institute of Colorado, CCCRICEnglewood, Colorado
- Sibley Memorial Hospital - a member of Johns Hopkins medicineWashington D.C., District of Columbia
- Georgetown UniversityWashington D.C., District of Columbia