Hypofractionated Stereotactic Body Radiation Therapy and Fluorouracil or Capecitabine With or Without Zoledronic Acid in Treating Patients With Locally Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial studies how well hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating patients with pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chi Lin, MD; Chi Lin, MD, PhD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Diphosphonates; Fluorouracil; Imidazole; Zoledronic Acid

Criteria

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the pancreas; patients with either initially diagnosed or recurrent locally advanced disease; the maximum dimension of the treatment target must be =<10 cm; locally advanced disease defined as: T 1-2N+MO or T3-4 NxMo, or borderline resectable and unresectable adenocarcinoma without distant metastatic disease or resectable T3-4 NxMo disease or M1 with controlled distant disease

• Patients with inoperable conditions with resectable disease (T1-2NoMo)

• Karnofsky performance status of 60% or better

• Patients who received recent chemotherapy for pancreatic cancer are eligible; patients who received chemotherapy > 5 years ago for malignancies other than pancreatic cancer are also eligible, provided that chemotherapy was completed > 5 years ago and that there is no evidence of the second malignancy at the time of study entry

• Patients who received radiation therapy > 5 years ago for malignancies other than pancreatic cancer and whose radiation therapy field is not overlapping with the 20% isodose line of current radiation field are eligible, provided that radiation therapy was completed > 5 years ago and that there is no evidence of the second malignancy at the time of study entry

• All malignant disease must be able to be encompassed within a single irradiation field

• Patients must have an absolute neutrophil count (ANC) greater than or equal to 1500/uL

• All patients must have radiographically assessable disease

• Platelet count greater than or equal to 100,000/uL

• Patients must have a serum creatinine less than or equal to 2.0 mg/dL and total bilirubin less than or equal to 2.0 mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of a biliary stent or percutaneous transhepatic drainage is acceptable; once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to 4.0 mg/dL or lower)

• Patients must have a calculated creatinine clearance of >= 35

• The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

Exclusion Criteria:

• Patients with a known allergy to Zometa or to antiemetics appropriate for administration in conjunction with protocol-directed therapy

• Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might jeopardize the ability of the patient to receive the therapy program outlined in this protocol with reasonable safety

• Pregnant and nursing women are excluded from this study

• Patients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years

• Patients with active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)

• Patients with known human immunodeficiency virus (HIV) infection, or hepatic insufficiency

• Patients may not be receiving or have received Zometa during/or within 3 weeks prior to treatment with Zometa