Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer

NCT01086332 | Terminated Phase 1 DMC

• 1 other identifier: 200905705
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to evaluate if nelfinavir works as a radiation sensitizer in combination with gemcitabine (a chemotherapy). We are also looking to establish the maximum dose of gemcitabine that is tolerated with the nelfinavir and radiation therapy, so the dose of gemcitabine is increased based on how previous trial participants tolerated their dose of gemcitabine.

Conditions

Pancreatic Neoplasms

Keywords

radiotherapy; gemcitabine; nelfinavir; neoplasms

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities

  Evaluating adverse events and their association to the treatment to determine the recommended phase II dose of gemcitabine.

  Six weeks

Secondary Outcomes (1)

• Surgical resection rate

  8 weeks

Study Arms (1)

phase 1/2

EXPERIMENTAL

An escalating study of gemcitabine when combined with 1250 mg of nelfinavir twice daily. Dose of gemcitabine is increased for new subjects based on the experiences and tolerance of prior subjects. When the maximum tolerated dose is identified, a recommended phase 2 dose will be assigned and further subjects will receive that dose.

Drug: Nelfinavir; Drug: Gemcitabine

Interventions

Nelfinavir DRUG

1250 mg twice daily

Also known as: Viracept

phase 1/2

Gemcitabine DRUG

Escalating doses of gemcitabine during concurrent radiation and nelfinavir therapy.

Also known as: Gemzar

phase 1/2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Closed to accrual.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Iowa: lead
• Holden Comprehensive Cancer Center: collaborator

Related Publications (4)

• Plastaras JP, Vapiwala N, Ahmed MS, Gudonis D, Cerniglia GJ, Feldman MD, Frank I, Gupta AK. Validation and toxicity of PI3K/Akt pathway inhibition by HIV protease inhibitors in humans. Cancer Biol Ther. 2008 May;7(5):628-35. doi: 10.4161/cbt.7.5.5728. Epub 2008 May 14.

  PMID: 18285707 BACKGROUND

• Gupta AK, Li B, Cerniglia GJ, Ahmed MS, Hahn SM, Maity A. The HIV protease inhibitor nelfinavir downregulates Akt phosphorylation by inhibiting proteasomal activity and inducing the unfolded protein response. Neoplasia. 2007 Apr;9(4):271-8. doi: 10.1593/neo.07124.

  PMID: 17460771 BACKGROUND

• Pore N, Gupta AK, Cerniglia GJ, Jiang Z, Bernhard EJ, Evans SM, Koch CJ, Hahn SM, Maity A. Nelfinavir down-regulates hypoxia-inducible factor 1alpha and VEGF expression and increases tumor oxygenation: implications for radiotherapy. Cancer Res. 2006 Sep 15;66(18):9252-9. doi: 10.1158/0008-5472.CAN-06-1239.

  PMID: 16982770 BACKGROUND

• Gupta AK, Cerniglia GJ, Mick R, McKenna WG, Muschel RJ. HIV protease inhibitors block Akt signaling and radiosensitize tumor cells both in vitro and in vivo. Cancer Res. 2005 Sep 15;65(18):8256-65. doi: 10.1158/0008-5472.CAN-05-1220.

  PMID: 16166302 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Nelfinavir; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bryan G. Allen, M.D., PhD

  University of Iowa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: May 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2015
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon request
• Access Criteria: Depending upon the data desired, a confidentiality / non-disclosure agreement may be required.