RECRUITING

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

Talk to us

Conditions

Locally Advanced Pancreatic CancerLAPCNab-paclitaxel +GemcitabineProton Therapy

Quick Navigation

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 purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.

Official Title

Phase I Study of Concurrent Nab-Paclitaxel + Gemcitabine With Hypofractionated, Ablative Proton Therapy for Locally Advanced Pancreatic Cancer

Quick Facts

Study Start:2019-04-02
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03652428

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Cytologic or histologic proof of adenocarcinoma of the pancreas.
  2. 2. Nonmetastatic pancreatic cancer. Metastatic disease includes spread to distant (non-regional) lymph nodes, organs, peritoneum and ascites.
  3. 3. Unequivocal radiographic findings contraindicating resection including, but not limited to, solid tumor contact with any of the following: 1) the SMA \>180º; 2) the celiac axis \>180º; 3) the first jejunal superior mesenteric artery (SMA) branch; 4) unreconstructible superior mesenteric vein (SMV)/portal vein due to tumor involvement or occclusion; 5) the most proximal draining jejunal branch into the SMV.
  4. 4. ECOG Performance Status 0 or 1.
  5. 5. Absolute neutrophil count ≥1,000/mm3
  6. 6. Platelet count ≥100,000/mm3
  7. 7. Creatinine ≤1.5 × upper limit of normal
  8. 8. Calculated creatinine clearance \>45 mL/min
  9. 9. Total bilirubin ≤2 mg/dL
  1. 1. Patients with resectable or borderline resectable pancreatic cancer are ineligible.
  2. 2. No prior definitive resection of pancreatic cancer.
  3. 3. No prior radiation therapy to the abdomen that would overlap fields required in this study. Prior radiotherapy for other disease is allowed.
  4. 4. No prior chemotherapy except for FOLFIRINOX, Gem-Abrax, or Gem-Cap. A patient may be registered for the trial while undergoing chemotherapy.
  5. 5. Any grade 4 toxicity prior to start of chemoradiotherapy that may be due to induction chemotherapy.
  6. 6. Greater than 2 dose reductions during induction chemotherapy.
  7. 7. Chronic concomitant treatment with strong inhibitors of CYP3A4. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to the start of study treatment. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.
  8. 8. Baseline Grade ≥ 2 neuropathy. Known Gilbert's disease or known homozygosity for UGAT1A1\*28 polymorphism.
  9. 9. Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry if they are in childbearing years/premenopausal.
  10. 10. Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with gemcitabine and nab-paclitaxel.
  11. 11. Non-compliance with induction chemotherapy.

Contacts and Locations

Study Contact

Jason Molitoris, MD
CONTACT
410-328-2328
jmolitoris@umm.edu
Jasmine A Newman, BS
CONTACT
410-369-5355
jasmine.newman@umm.edu

Principal Investigator

Jason Molitoris, MD
PRINCIPAL_INVESTIGATOR
University of Maryland/Maryland Proton Treatment Center

Study Locations (Sites)

MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
University of Maryland Medical Center/Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Jason Molitoris, MD, PRINCIPAL_INVESTIGATOR, University of Maryland/Maryland Proton Treatment Center

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 Date2019-04-02
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-04-02
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • LAPC
  • Nab-paclitaxel +Gemcitabine
  • Proton Therapy

Additional Relevant MeSH Terms

  • Locally Advanced Pancreatic Cancer