Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer

Last updated: September 2, 2020
Sponsor: Jean-Luc Van Laethem
Overall Status: Completed

Phase

1

Condition

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT01715142
2012-003592-19
  • Ages > 18
  • All Genders

Study Summary

Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease with conventional treatments having little impact on disease course. Novel approaches are urgently needed to address inherent resistance to the current therapies and to identify new drugs or combinations that will have a high chance of success in pancreatic cancer patients. This proof-of-concept trial is studying the "dynamic" tumor response after the administration of a short course of gemcitabine and nab-paclitaxel (Abraxane) (a) during a window interval (4 weeks= 1 cycle) before surgery in resectable pancreatic cancer (cohort 1 = 21 patients) and (b) during at least 8 weeks (2 cycles) in locally advanced or metastatic pancreatic cancer (cohort 2 = 10 patients).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histo(cyto)logically proven ductal pancreatic adenocarcinoma;

  • Resectable or potentially resectable tumor; resectability assessed during amultidisciplinary meeting with expert surgeon and radiologist (cohort 1), or locallyadvanced 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, creatinineclearance (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 hasnot undergone a hysterectomy or tubal ligation of who has not been naturallypostmenopausal for at least 24 consecutive months, must have a negative serum or urinepregnancy test prior to treatment. All WCBP, all sexually active male patients, andall partners of patients must agree to use adequate methods of birth controlthroughout the study;

  • Signed informed consent.

Exclusion

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 theuterine cervix treated with a curative intent and any other tumor in completeremission 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 ordiastolic pressure > 100 mm under well conducted antihypertensive treatment), QTprolongation;

  • Major uncontrolled infection;

  • Severe hepatic impairment;

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

  • Pregnant or lactating women, or patients of both genders with procreative potentialnot using adequate contraceptive methods;

  • Patients receiving or having received any investigational treatment within 4 weeksprior to study entry, or participating to another clinical study; patients previouslyenrolled into this study.

Study Design

Total Participants: 23
Study Start date:
March 21, 2013
Estimated Completion Date:
April 30, 2017

Study Description

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 tumors.

Connect with a study center

  • Antwerp University Hospital (UZA)

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • Erasme University Hospital (ULB)

    Brussels, 1070
    Belgium

    Site Not Available

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