Close
Close

Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Access Programs

Disease Information

Descriptive Information
Brief Title † Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates
Official Title † Perioperative Therapy for Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma With Molecular Correlates
Brief Summary The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).
Detailed Description Patients in both cohorts will receive a total of 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine, followed by re-staging CT scan, if re-staging CT does not show evidence of metastatic disease. Patients will receive SBRT and definitive surgical resection. Subsequently, patients will receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine. Each cycle of combination chemotherapy will be a total of 4 weeks. Patients will be evaluated for response at completion of the 3 cycles of neoadjuvant combination chemotherapy with CT scans of chest, abdomen and pelvis. Patients will undergo surveillance CT scan at 3-month intervals until evidence of disease progression.
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † R0 resection rates in each cohort as measured by macroscopically complete tumor removal with negative microscopic surgical margins
Secondary Outcome Measure † Number of participants with treatment related adverse events as assessed by CTCAE v.4.03
Condition † Pancreatic Cancer Pancreatic Adenocarcinoma Pancreas Ductal Adenocarcinoma
Intervention † DrugNab-paclitaxel and gemcitabine for R-PDAC Patients
Study Arms / Comparison Groups Nab-paclitaxel/Gemcitabine for R-PDAC Nab-paclitaxel and gemcitabine, for R-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy. Nab-paclitaxel/Gemcitabine for BR-PDAC Nab-paclitaxel and gemcitabine, for BR-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 50
Start Date † December 30, 2016
Completion Date May 2018
Primary Completion Date May 2018
Eligibility Criteria † Inclusion Criteria: 1. Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma. 2. No evidence of distant metastasis representing stage IV metastatic disease. 3. R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture. 4. BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short-segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall. 5. Age > 18 years old 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Patients must have adequate bone marrow function: - Platelets >100,000 cells/mm3 - Hemoglobin > 9.0 g/dL - Absolute Neutrophil Count > 1,500 cells/mm3 8. Patients must have adequate liver function: - aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) 50 mL/min calculated using the Cockcroft-Gault equation. 10. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. 11. Negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential. 12. Patients must have grade 1). 8. Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months. 9. Serious, uncontrolled, concurrent infection(s) requiring antibiotics. 10. Pregnant or breastfeeding women: positive pregnancy test within 7 days of starting treatment. 11. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer. 12. Participation in any investigational drug study within 4 weeks preceding the start of study treatment. 13. Patients with external biliary drains.
Gender All
Ages 18 Years - 101 Years
Accepts Healthy Volunteers No
Contacts †† Amy Wallace, 720-848-2538, amy.wallace@ucdenver.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02723331
Organization ID 15-0150.cc
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of Colorado, Denver
Collaborators †† Celgene Corporation
Investigators † Principal Investigator: Wells Messersmith, MD, University of Colorado, Denver
Information Provided By
Verification Date June 2017
First Received Date † March 24, 2016
Last Updated Date June 14, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
Find a Clinical Trial
Related Videos
by Abidemi Uruejoma
542 views
by Abidemi Uruejoma
1,935 views
Free Newsletter