Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
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.
Study Objective(s):
A) Primary end-points:
1. Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma
density.
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
metabolic activity.
The following studies will be performed prior and after treatment administration:
- 18FDG-PET/CT scan;
- Ultrasound Elastography;
- IHC:
1. SPARC;
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
follow:
- nab-paclitaxel will be administered at 125 mg/m2 as intravenous (i.v.) infusion over
30 minutes;
- 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.
Inclusion Criteria:
- Patients who are 18 years or older;
- Patients with resectable/resectable borderline pancreatic cancer;
- Adequate hematopoietic, hepatic and renal function:
- Neutrophil count > o = 1.5 x 109/L;
- Platelet count > o = 100 x 109/L;
- Bilirubin ≤ 1.5 x ULN;
- AST and/or ALT ≤ 2.5 x ULN;
- Serum creatinine ≤ 1.5 x ULN.
- Investigators must ensure that patients enrolled in the study will be available for
all study procedures, including tumor biopsy, surgical treatment, and follow up.
- Investigators must ensure that patients have the ability to understand the
requirements of the study and provide signed informed consent.
- Signed Informed Consent.
Exclusion Criteria:
- Active or uncontrolled infections or serious illnesses or medical conditions that
could interfere with patient eligibility for treatment;
- History of any psychiatric condition that might impair patient's ability to
understand or to comply with the requirements of the study or to provide informed
consent;
- Concurrent anticancer therapy;
- Pregnant or breast-feeding women (documented methods of birth control are required in
those with reproductive potential);
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to study drugs;
- History of life threatening reaction to gemcitabine or abraxane;
- Previous exposure to other agents or treatment procedure as radiotherapy for the
treatment of pancreatic cancer.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect of nab-paclitaxel on pancreatic cancer stroma, new vessel formation and tumor cell metabolism.
Outcome Description:
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.
Outcome Time Frame:
up to 18 months
Safety Issue:
No
Principal Investigator
Manuel Hidalgo, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centro Integral Oncologico Clara Campal (CIOCC), Centro National Investigacion Oncologica (CNIO)
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
ABX271-PA09EU
NCT ID:
NCT01442974
Start Date:
January 2011
Completion Date:
June 2012
Related Keywords:
- Pancreatic Cancer
- nab-paclitaxel
- neoadjuvant treatment
- SPARC
- Pancreatic Cancer
- Pancreatic Neoplasms
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