Clinical Trials Directory

Trials / Completed

CompletedNCT01959672

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

A Phase II Study of Neoadjuvant Chemotherapy With and Without Immunotherapy to CA125 (Oregovomab) Followed by Hypofractionated Stereotactic Radiotherapy & Concurrent HIV Protease Inhibitor Nelfinavir in Locally Advanced Pancreatic Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
11 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of neoadjuvant chemotherapy, (gemcitabine \[gemcitabine hydrochloride\], leucovorin \[leucovorin calcium\], fluorouracil \[5-FU\]) with or without oregovomab, followed by hypofractionated stereotactic radiotherapy (SRT) concurrently with nelfinavir (nelfinavir mesylate) in patients with locally advanced pancreatic cancer that is cancer antigen (CA)125 positive (\>= 10) or CA125 negative (\< 10). SECONDARY OBJECTIVES: I. To assess the safety of neoadjuvant chemotherapy, (gemcitabine, leucovorin, 5-FU) with or without oregovomab, followed by SRT concurrently with nelfinavir in patients with locally advanced pancreatic cancer that is CA125 positive (\>= 10) or CA125 negative (\< 10). II. To assess the cellular and humoral immune responses to active immunotherapy with oregovomab/monoclonal antibody in patients with pancreas cancer with CA125 level greater than 10 undergoing chemotherapy and radiation treatments. TERTIARY OBJECTIVES: I. To evaluate tumor and organ motion with 4-dimensional (4D) computed tomography (CT) and respiratory gating system. II. To evaluate the effect of tumor/organ motion on the dosimetry, local control and survival. III. To evaluate inter- and intra-fractional target motion with Calypso system. OUTLINE: CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV), leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses. IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate orally (PO) twice daily (BID) for 5 weeks beginning on day 15 of week 9. STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Conditions

Interventions

TypeNameDescription
PROCEDURE4-Dimensional Computed TomographyCorrelative studies
DRUGFluorouracilGiven IV
DRUGGemcitabine HydrochlorideGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGLeucovorin CalciumGiven IV
DRUGNelfinavir MesylateGiven PO
BIOLOGICALOregovomabGiven IV
RADIATIONStereotactic Body Radiation TherapyUndergo SBRT
PROCEDURETherapeutic Conventional SurgeryUndergo surgical resection

Timeline

Start date
2013-09-06
Primary completion
2018-04-01
Completion
2018-12-01
First posted
2013-10-10
Last updated
2023-10-10
Results posted
2019-11-15

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01959672. Inclusion in this directory is not an endorsement.