RECRUITING

A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators hypothesize that intensification of local therapy will lead to improvements in local control and survival in patients with unresectable and borderline resectable pancreatic cancer. We propose to do this by combining nab-paclitaxel concurrently with dose-escalated radiation therapy. In the first part of this phase I study (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held constant at a standardly accepted level. The use of this novel chemoradiotherapy regimen will take advantage of nab-paclitaxel's specific anti-tumor and anti-stromal properties, which may enhance the efficacy of radiation therapy, and thereby improve local control. After the MTD of nab-paclitaxel had been determined, a second arm in sub-trial 1 will evaluate the addition of paricalcitol to nab-paclitaxel concurrently with dose-escalated radiation therapy. In addition, after the MTD of the nab-paclitaxel is reached in sub-trial 1 arm A, in the second part of this study (sub-trial 2), we will administer nab-paclitaxel at the determined MTD concurrently with escalated doses of radiation. We will utilize IMRT or protons to safely deliver high doses of radiation while maximally sparing surrounding normal tissue. Patients will also preferentially have 2-3 fiducial markers placed in or around the tumor for daily localization. Chemotherapy before and/or after chemoradiotherapy may be given as per standard of care. Correlative tissue and serum biomarkers are an important, but optional, part of this study.

Official Title

A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer

Quick Facts

Study Start:2014-07
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02207465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed adenocarcinoma of the pancreas.
  2. * Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014):
  3. * Greater than 180 degrees of SMA encasement
  4. * Any celiac abutment
  5. * Unreconstructible SMV/portal occlusion
  6. * Aortic invasion or encasement
  7. * Nodal metastases beyond the field of resection Borderline resectable
  8. * Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen
  9. * Encasement of the SMV/portal vein but without encasement of the nearby arteries
  10. * Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting.
  11. * Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis
  12. * Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall
  13. * Age \> 18 years.
  14. * ECOG performance status of ≤ 1.
  15. * Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST \< 5 times the upper limit of normal.
  16. * Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial.
  17. * Patients must be able to provide written informed consent.
  1. * Distant metastatic disease.
  2. * Prior history of abdominal radiation therapy.
  3. * Prior systemic therapy for pancreatic cancer.
  4. * Prior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer). In-situ carcinoma is allowed.
  5. * Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
  6. * Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study.
  7. * Pregnant women, women planning to become pregnant and women that are nursing

Contacts and Locations

Study Contact

Edgar Ben-Josef, MD
CONTACT
215-662-6567
Edgar.Ben-Josef@pennmedicine.upenn.edu

Principal Investigator

Edgar Ben-Josef, MD
PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine

Study Locations (Sites)

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Chester County Hospital
West Chester, Pennsylvania, 19380
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Edgar Ben-Josef, MD, PRINCIPAL_INVESTIGATOR, Abramson Cancer Center at Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-07
Study Completion Date2025-12

Study Record Updates

Study Start Date2014-07
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy
  • Borderline Resectable Pancreatic Cancer Treated With Chemoradiotherapy