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

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Aug 28, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for locally advanced pancreatic cancer, which is a type of cancer that cannot be easily removed with surgery. The study is testing a combination of two chemotherapy drugs, nab-paclitaxel and gemcitabine, along with a special type of radiation therapy called proton therapy. The main goal is to find out the highest safe doses of these treatments that can be given together. Participants in the trial will receive proton therapy once a day from Monday to Friday for three weeks and will also take chemotherapy on each of those Mondays.

To be eligible for this trial, participants must have a confirmed diagnosis of pancreatic adenocarcinoma, which is a common type of pancreatic cancer, and their cancer must not have spread to other parts of the body. Other important criteria include having a good performance status, which means they can carry out daily activities, and meeting certain health measurements related to blood counts and kidney function. This trial is currently recruiting participants, and it is open to adults aged 18 to 75. If you or someone you know is considering joining this trial, it could be an opportunity to access a potentially effective treatment while contributing to important research in pancreatic cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Cytologic or histologic proof of adenocarcinoma of the pancreas.
• • 2. Nonmetastatic pancreatic cancer. Metastatic disease includes spread to distant (non-regional) lymph nodes, organs, peritoneum and ascites.
• • 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. ECOG Performance Status 0 or 1.
• • 5. Absolute neutrophil count ≥1,000/mm3
• • 6. Platelet count ≥100,000/mm3
• • 7. Creatinine ≤1.5 × upper limit of normal
• • 8. Calculated creatinine clearance \>45 mL/min
• • 9. Total bilirubin ≤2 mg/dL
• Exclusion Criteria:
• • 1. Patients with resectable or borderline resectable pancreatic cancer are ineligible.
• • 2. No prior definitive resection of pancreatic cancer.
• • 3. No prior radiation therapy to the abdomen that would overlap fields required in this study. Prior radiotherapy for other disease is allowed.
• • 4. No prior chemotherapy except for FOLFIRINOX, Gem-Abrax, or Gem-Cap. A patient may be registered for the trial while undergoing chemotherapy.
• • 5. Any grade 4 toxicity prior to start of chemoradiotherapy that may be due to induction chemotherapy.
• • 6. Greater than 2 dose reductions during induction chemotherapy.
• • 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. Baseline Grade ≥ 2 neuropathy. Known Gilbert's disease or known homozygosity for UGAT1A1\*28 polymorphism.
• • 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. Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with gemcitabine and nab-paclitaxel.
• • 11. Non-compliance with induction chemotherapy.