A Phase II Trial of Weekly Gemcitabine Hydrochloride and Bevacizumab in Combination With Abdominal Radiation Therapy in Patients With Localized Pancreatic Cancer
- Determine the objective response rate in patients treated with concurrent bevacizumab,
gemcitabine hydrochloride, and abdominal radiotherapy.
- Determine the quantitative toxicity associated with the delivery of this regimen in
- Determine the 1-year and median survival of patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the patterns of recurrence in the entire population of patients treated with
this regimen and in the subgroup that is resected for cure.
- Determine the safety of this regimen in these patients.
- Evaluate the surgical experience of patients who undergo surgical resection after
completion of protocol-directed therapy.
- Evaluate the toxicity associated with surgical resection in these patients.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of
courses 1 and 3 and on days 1, 8, and 15 of course 2. Patients also receive bevacizumab IV
over 30-90 minutes on days 1 and 15 of course 1, on days 8 and 22 of course 2, and on day 8
of course 3. Treatment repeats every 3-4 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity. Beginning on day 1 of the second course of
chemotherapy, patients undergo concurrent abdominal radiotherapy once daily, five days a
week, for 3 weeks.
Patients are evaluated at week 10. Patients whose disease deemed resectable after study
treatment undergo standard pancreatic resection at least 6 weeks after completion of
bevacizumab. Patients who remain unresectable and have not progressed after completion of
chemoradiotherapy may begin maintenance therapy comprising gemcitabine hydrochloride IV over
30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15.
Treatment with gemcitabine hydrochloride and bevacizumab repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
After 10 weeks of concurrent therapy
William Small, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Northwestern University||Chicago, Illinois 60611|