Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Sudershan Bhatia, University of Iowa
ClinicalTrials.gov Identifier:
NCT01086332
First received: March 11, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: Nelfinavir
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Dose limiting toxicities [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Evaluating adverse events and their association to the treatment to determine the recommended phase II dose of gemcitabine.


Secondary Outcome Measures:
  • Surgical resection rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Evaluate the number of subjects who are now surgically resectable and then correlate the pathological outcomes with treatment (i.e., tumor cell kill).


Enrollment: 7
Study Start Date: May 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phase 1/2
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
1250 mg twice daily
Other Name: Viracept
Drug: Gemcitabine
Escalating doses of gemcitabine during concurrent radiation and nelfinavir therapy.
Other Name: Gemzar

Detailed Description:

This trial utilizes gemcitabine (a chemotherapy agent commonly used for pancreatic cancer) and nelfinavir (an anti-retroviral agent FDA-approved for use in HIV+ patients) in addition to radiation therapy for treatment of borderline resectable pancreatic cancer. The trial seeks to determine the maximum tolerated dose of gemcitabine when administered concurrently with radiation therapy and 1250 mg nelfinavir twice daily.

The gemcitabine and radiation is standard; the dose of gemcitabine does vary nationally and internationally as to what the 'best dose' is. Administered weekly, doses can range from 400 mg/m2 to 1000 mg/m2. Thus, this is why the proposed clinical trial escalates the gemcitabine.

The gemcitabine will be administered weekly during radiation therapy for a total of 6 cycles. After completion of radiation therapy, the subjects will be evaluated by the surgeons for resectability. This ends the active portion of the clinical trial; the subjects will be followed for long-term progression free survival and for overall survival.

Primary endpoints for this trial are identifying the maximum tolerated dose of gemcitabine when administered concurrently with nelfinavir and radiation therapy (the phase I portion of this study) and the rate of resectability (typically, utilizing gemcitabine plus radiation therapy will convert up to 30% of patients from borderline resectable to resectable) for the phase II portion of the study.

Interim analyses and stopping rules are in place if an effect size is not observed in the therapeutic group compared to published reports of response to standard chemoradiation for borderline resectable cases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Closed to accrual.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086332

Locations
United States, Iowa
The Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Holden Comprehensive Cancer Center
Investigators
Study Director: Sudershan K. Bhatia, M.D., PhD The University of Iowa
  More Information

Publications:
Responsible Party: Sudershan Bhatia, Assistant Professor of Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT01086332     History of Changes
Other Study ID Numbers: 200905705
Study First Received: March 11, 2010
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
radiotherapy
gemcitabine
nelfinavir
neoplasms

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Protease Inhibitors
Nelfinavir
Gemcitabine
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 27, 2014