CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Fluorouracil +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01959672
NCT01959672Phase 2Completed

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

University of Nebraska·interventional·Posted Oct 10, 2013·Updated Oct 10, 2023

In Brief

A Phase 2 clinical trial evaluating 4-Dimensional Computed Tomography, Fluorouracil, and 7 other interventions for Pancreatic Adenocarcinoma and 8 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartSep 6, 2013
Primary CompletionApr 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.7 years ago

Interventions

4-Dimensional Computed Tomographyprocedure

Correlative studies

Fluorouracildrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV

Nelfinavir Mesylatedrug

Given PO

Oregovomabbiological

Given IV

Stereotactic Body Radiation Therapyradiation

Undergo SBRT

Therapeutic Conventional Surgeryprocedure

Undergo surgical resection