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

March 11, 2010
October 18, 2013
May 2009
July 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01086332 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer
A Phase I/II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Locally Advanced Pancreatic Cancer

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Neoplasms
  • Drug: Nelfinavir
    1250 mg twice daily
    Other Name: Viracept
  • Drug: Gemcitabine
    Escalating doses of gemcitabine during concurrent radiation and nelfinavir therapy.
    Other Name: Gemzar
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7
October 2014
July 2011   (final data collection date for primary outcome measure)

Closed to accrual.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01086332
200905705
Yes
Sudershan Bhatia, University of Iowa
University of Iowa
Holden Comprehensive Cancer Center
Study Director: Sudershan K. Bhatia, M.D., PhD The University of Iowa
University of Iowa
October 2013

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