Know Cancer

forgot password

Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Patients With Potentially Operable, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Phase 0
18 Years
Not Enrolling
Pancreatic Adenocarcinoma Resectable, Pancreatic Adenocarcinoma Locally Advanced, Pancreatic Adenocarcinoma Metastatic

Thank you

Trial Information

Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Patients With Potentially Operable, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is a hypoperfused tumor, characterized by a high stroma density precluding
cytotoxics delivery to the epithelial tumoral compartment. There is thus a rationale for
combining chemotherapy and antistromal drugs like nab-paclitaxel (Abraxane), a solvent
(Cremophor® EL)-free, albumin-bound form of paclitaxel that has been initially developed to
reduce the toxicities associated with Taxol injection while maintaining or improving its
chemotherapeutic effect. This unique protein formulation provides a novel approach of
increasing intra-tumoral concentrations of the drug by a receptor-mediated transport process
allowing transcytosis across the endothelial cell.

Abraxane has been approved for commercialization in 38 countries, including the US, Canada,
the EU, Australia, China, India and Korea for the treatment of women with metastatic breast
cancer. Abraxane alone and in combination is being evaluated in a number of cancers,
including metastatic melanoma, non-small cell lung cancer, pancreatic cancer and other solid

Inclusion Criteria:

- Histo(cyto)logically proven ductal pancreatic adenocarcinoma;

- Resectable or potentially resectable tumor; resectability assessed during a
multidisciplinary meeting with expert surgeon and radiologist (cohort 1), or locally
advanced and/or metastatic tumor (cohort 2);

- First line chemotherapy;

- Age > 18 years;

- WHO performance status (PS) grade 0 or 1;

- Absolute neutrophil count > 1.5 x 10 9 / L, platelets > 100 x 10 9/ L, creatinine
clearance (Cockcroft and Gault formula) > 60 ml/min, haemoglobin level > 10 g/dl
(transfusions authorized), bilirubin<1.5 g/dl;

- Optimal biliary drainage;

- Women of child-bearing potential (WCBP), defined as a sexually mature woman who has
not undergone a hysterectomy or tubal ligation of who has not been naturally
postmenopausal for at least 24 consecutive months, must have a negative serum or
urine pregnancy test prior to treatment. All WCBP, all sexually active male patients,
and all partners of patients must agree to use adequate methods of birth control
throughout the study;

- Signed informed consent.

Exclusion Criteria:

- Previous anticancer therapy for the pancreatic adenocarcinoma;

- Biliary obstruction without endoscopic biliary drainage;

- Any contre-indication for surgery;

- Prior malignancy (except non-melanoma skin cancer, and in situ carcinoma of the
uterine cervix treated with a curative intent and any other tumor in complete
remission with a disease-free interval > 3 years);

- Uncontrolled congestive heart failure or angina pectoris, myocardial infarction
within 1 year prior to study entry, uncontrolled hypertension (systolic pressure >
160 mm or diastolic pressure > 100 mm under well conducted antihypertensive
treatment), QT prolongation;

- Major uncontrolled infection;

- Severe hepatic impairment;

- Any medical, psychological, or social condition, which, in the opinion of the
investigator, could hamper patient's compliance to the study protocol and/or
assessment/interpretation of the data;

- Pregnant or lactating women, or patients of both genders with procreative potential
not using adequate contraceptive methods;

- Patients receiving or having received any investigational treatment within 4 weeks
prior to study entry, or participating to another clinical study; patients previously
enrolled into this study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dynamic tumor response rate as defined by a 40% modification of tumoral perfusion and cellular density parameters.

Outcome Description:

In order to detect changes in the tumor microenvironment and to monitor treatment efficacy, Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI) and Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI) constitute tools more and more used. The acquired data can be analyzed using a pharmacokinetic model to obtain quantitative parameters relative to tissue perfusion and vascular permeability (Ktrans, a volume transfer constant of contrast agent between blood plasma and the extravascular extracellular space; Apparent Coefficient Diffusion as a surrogate marker of tissue cellularity). DCE/DW-MRI will be achieved before each chemotherapy treatment (and also before surgery for resectable patients). Each patient will be his/her own control by comparing serial imaging results with those of the baseline MRI.

Outcome Time Frame:

4 weeks (duration of 1 cycle of neoadjuvant chemotherapy for resectable patients); 8 weeks (duration of 2 cycles of treatment for locally advanced and metastatic patients)

Safety Issue:


Principal Investigator

Jean-Luc Van Laethem, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasme University Hospital


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

December 2012

Completion Date:

September 2015

Related Keywords:

  • Pancreatic Adenocarcinoma Resectable
  • Pancreatic Adenocarcinoma Locally Advanced
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic cancer
  • Nab-paclitaxel
  • Gemcitabine
  • Neoadjuvant chemotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms