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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00705393 |
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs, such as nelfinavir, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as gemcitabine, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic radiation therapy and nelfinavir together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy and nelfinavir when given together with gemcitabine, leucovorin, and fluorouracil in treating patients with locally advanced pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: nelfinavir mesylate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: hypofractionated radiation therapy Radiation: stereotactic body radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase 1 Study of Hypofractionated Stereotactic Radiotherapy and Concurrent HIV Protease Inhibitor Nelfinavir as Part of a Neoadjuvant Regimen in Patients With Locally Advanced Pancreatic Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of stereotactic radiotherapy (SRT) and concurrent nelfinavir.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed adenocarcinoma of the pancreas
All malignant disease must be encompassable within a single irradiation field
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent drugs that are contraindicated with nelfinavir, including any of the following:
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-6805 | |
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 |
Principal Investigator: | Chi Lin, MD, PhD | University of Nebraska |
Study ID Numbers: | CDR0000598330, UNMC-44107, UNMC-441-07-FB |
Study First Received: | June 25, 2008 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00705393 History of Changes |
Health Authority: | Unspecified |
stage III pancreatic cancer adenocarcinoma of the pancreas |
Antimetabolites Immunologic Factors Pancreatic Neoplasms Leucovorin Pancrelipase Anti-Retroviral Agents Vitamins Micronutrients Gemcitabine Nelfinavir Endocrine Gland Neoplasms HIV Protease Inhibitors Anti-HIV Agents Digestive System Neoplasms Vitamin B Complex |
Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Endocrine System Diseases Trace Elements Antiviral Agents Immunosuppressive Agents Protease Inhibitors Calcium, Dietary Digestive System Diseases Radiation-Sensitizing Agents HIV Infections Fluorouracil Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Leucovorin Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Vitamins Micronutrients Nelfinavir |
Gemcitabine Endocrine Gland Neoplasms HIV Protease Inhibitors Anti-HIV Agents Digestive System Neoplasms Vitamin B Complex Growth Substances Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Digestive System Diseases |