Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Study Phase: Pilot study to assess nab-paclitaxel in combination with gemcitabine effects on
pancreatic cancer stroma and tumor metabolism.
A) Primary end-points:
1. Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma
2. Evaluate the effect of nab-paclitaxel on tumor vessels formation.
3. Evaluate the effect of nab-paclitaxel on tumor metabolism.
B) Secondary end-point:
1. Evaluate combination activity in relation with changes in tumor stroma and tumor
The following studies will be performed prior and after treatment administration:
- 18FDG-PET/CT scan;
- Ultrasound Elastography;
2. Microvessel Density (CD-31, VEGF-A);
3. Stroma density (SMA and Collagen I).
Study population and Number of subject: A total of 15 pancreatic cancer patients with
resectable/resectable borderline disease are expected to be enrolled.
Study design and schedule: This is a pilot study to evaluate the effect of nab-paclitaxel on
tumor stroma in pancreatic cancer patients. The study will be conducted in two parts:
Part A: Patients diagnosed with resectable/resectable pancreatic cancer will be screened for
SPARC expression. Fifteen, SPARC positive patients, will be enrolled in the study and
treated with nab-paclitaxel in combination with gemcitabine. Patients will be treated as
- nab-paclitaxel will be administered at 125 mg/m2 as intravenous (i.v.) infusion over
- followed by gemcitabine 1000 mg/m2 i.v. infusion over 30 minutes;
Treatment will be delivered weekly, for 3 weeks (on day 1, 8, and 15 over 28 days cycle)
followed by a week of rest, for two cycles of treatment.
Part B: At the end of treatment tumors will be surgically resected according to standard
surgical procedure for the treatment of pancreatic cancer.
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.
Primary End-point: Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density. Evaluate the effect of nab-paclitaxel on tumor vessels formation. Evaluate the effect of nab-paclitaxel on tumor metabolism by PET-CT scan measuring pre-treatment versus post-treatment glucose uptake.
up to 18 months
Manuel Hidalgo, MD, PhD
Centro Integral Oncologico Clara Campal (CIOCC), Centro National Investigacion Oncologica (CNIO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios