A Phase I/II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicities
Evaluating adverse events and their association to the treatment to determine the recommended phase II dose of gemcitabine.
Sudershan K. Bhatia, M.D., PhD
The University of Iowa
United States: Institutional Review Board
|The Holden Comprehensive Cancer Center||Iowa City, Iowa 52242|