This phase I trial studies the side effects and best dose of radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation when given together in treating patients with pancreatic cancer. Radiation therapy uses high energy x-rays and/or protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02207465.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when administered with concurrent radiotherapy in unresectable and borderline resectable pancreatic cancer.
II. To determine the maximum tolerated dose of radiation when delivered with concurrent nab-paclitaxel, administered at the maximum tolerated dose (MTD), in unresectable and borderline resectable pancreatic cancer.
SECONDARY OBJECTIVES:
I. To estimate the rates of local progression and survival in unresectable patients treated with this regimen.
II. To estimate the rates of R0 resection and survival in borderline resectable patients.
III. To assess quality of life in patients treated with this regimen.
IV. Assess the relationship of caveolin-1, secreted protein, acidic, cysteine-rich (osteonectin) (SPARC) and SMAD family member 4 (DPC4) expression with response to therapy.
V. Evaluate the feasibility of collecting circulated tumor cells (CTCs) and tumor microvesicles and assess their utility as novel biomarkers.
OUTLINE: This is a dose-escalation study.
INDUCTION: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CONCURRENT CHEMORADIOTHERAPY: Patients undergo intensity modulated radiation therapy and/or proton radiation therapy 5 days a week for 5 weeks and receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.
SURGERY: Four weeks after completion of concurrent chemoradiotherapy, patients who are deemed resectable undergo surgery. Patients who are still deemed unresectable may receive 4 additional courses of gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation treatment.
After completion of study treatment, patients are followed up periodically for 3 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorEdgar Ben-Josef
