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Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01086332
Recruitment Status : Terminated (Toxicities, lack of funding)
First Posted : March 15, 2010
Last Update Posted : November 13, 2018
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Bryan Allen, University of Iowa

Tracking Information
First Submitted Date  ICMJE March 11, 2010
First Posted Date  ICMJE March 15, 2010
Last Update Posted Date November 13, 2018
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
Dose limiting toxicities [ Time Frame: Six weeks ]
Evaluating adverse events and their association to the treatment to determine the recommended phase II dose of gemcitabine.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
Surgical resection rate [ Time Frame: 8 weeks ]
Evaluate the number of subjects who are now surgically resectable and then correlate the pathological outcomes with treatment (i.e., tumor cell kill).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer
Official Title  ICMJE A Phase I/II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neoplasms
Intervention  ICMJE
  • Drug: Nelfinavir
    1250 mg twice daily
    Other Name: Viracept
  • Drug: Gemcitabine
    Escalating doses of gemcitabine during concurrent radiation and nelfinavir therapy.
    Other Name: Gemzar
Study Arms  ICMJE 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.
Interventions:
  • Drug: Nelfinavir
  • Drug: Gemcitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
7
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2010)
70
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Closed to accrual.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01086332
Other Study ID Numbers  ICMJE 200905705
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data are shared upon request. Contact the clinical research team.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Upon request
Access Criteria: Depending upon the data desired, a confidentiality / non-disclosure agreement may be required.
Responsible Party Bryan Allen, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Holden Comprehensive Cancer Center
Investigators  ICMJE
Study Director: Bryan G. Allen, M.D., PhD University of Iowa
PRS Account University of Iowa
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP