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Phase 2 N=11 Treatment

Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer

Pancreatic Adenocarcinoma · Resectable Pancreatic Carcinoma · Stage I Pancreatic Cancer · Stage IA Pancreatic Cancer · Stage IB Pancreatic Cancer

Enrolled (actual)
11
Serious AEs
54.6%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Progressive Disease, — 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
4-Dimensional Computed Tomography (Procedure); Fluorouracil (Drug); Gemcitabine Hydrochloride (Drug); Laboratory Biomarker Analysis (Other); Leucovorin Calcium (Drug); Nelfinavir Mesylate (Drug); Oregovomab (Biological); Stereotactic Body Radiation Therapy (Radiation); Therapeutic Conventional Surgery (Procedure)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
University of Nebraska
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Progressive Disease,
2
SECONDARY
Distant Failure-free Survival
11
SECONDARY
Overall Survival
14.4
SECONDARY
Surgical Complete Resection (Negative Margin) Rate
4
SECONDARY
Tumor Response Rate, Evaluated on the Pathology Specimen
2; 1; 1

Summary

This phase II trial studies how well combination chemotherapy with or without oregovomab followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in treating patients with pancreatic cancer that has spread to nearby organs or tissues. Drugs used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and fluorouracil, 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. Monoclonal antibodies, such as oregovomab, can block tumor growth in different ways by targeting certain cells. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy with or without oregovomab followed by SBRT and nelfinavir mesylate may kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Pathologically confirmed adenocarcinoma of the pancreas; patients have resectable borderline resectable disease, or unresectable disease with no evidence of distant metastases or peritoneal disease; the maximum dimension of the tumor must be = 5 years ago for malignancies other than pancreatic cancer are 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
  • All patients must have radiographically assessable disease
  • Absolute neutrophil count (ANC) greater than or equal to 1500/uL
  • Platelet count greater than or equal to 100,000/uL
  • Serum creatinine less than or equal to 2.0 mg/dL
  • 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 biliary stent (7 French or greater) or percutaneous transhepatic drainage are acceptable; once biliary drainage has been established, institution of gemcitabine therapy may proceed when the total bilirubin falls to = = 10 to participate in the immunotherapy aspect of the trial and receive oregovomab; if the patient has CA125 >= 10 who is not eligible to receive oregovomab (e.g. allergic to the drug) but is eligible for the rest of treatment, this patient should be accrued to the part of protocol without oregovomab

Exclusion Criteria

  • Patients who cannot undergo staging laparoscopy; for example, this may include patients with a prior history of multiple abdominal operations in which laparoscopy may not be technically feasible or potentially harmful; the patient is eligible if they have a common bile duct stent adjacent to the tumor that may be used as an internal marker, or if the patient has already had a staging laparoscopy without marker implantation and the markers can be implanted (by interventional radiology) prior to the beginning of radiation therapy
  • Patients with a known allergy to murine proteins or have had a documented anaphylactic reaction or allergy to any of chemotherapy agents used in this protocol, oregovomab, 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 who cannot take oral medications
  • Patients may not be receiving or have received any other investigational agents during/or within 1 month prior to treatment with oregovomab or nelfinavir
  • Patients with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythemat
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01959672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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