A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer
- Determine time to disease progression in patients with previously untreated metastatic
adenocarcinoma of the pancreas treated with gemcitabine, cisplatin, and bevacizumab.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the objective response rate in patients treated with this regimen.
- Determine the efficacy of this regimen, in terms of the proportion of patients with ≥ a
50% decline in the CA19-9 biomarker, in these patients.
- Determine the median survival of patients treated with this regimen.
- Correlate serum markers of angiogenesis and circulating tumor micrometastases with
clinical outcome of patients treated with this regimen.
OUTLINE: This is an open-label, non-randomized study.
Patients receive gemcitabine IV over 100 minutes, cisplatin IV over 30-60 minutes, and
bevacizumab* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up
to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may
receive additional study treatment at the discretion of the investigator.
NOTE: *Patients may continue to receive other components of therapy if bevacizumab is
discontinued due to toxicity.
After completion of study treatment, patients are followed at 28 days and then monthly
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 12-18
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
Andrew Ko, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|