Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.
Drug: Infusional 5-Fluorouracil
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer|
- Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Response Rates Defined by RECIST 1.0 [ Time Frame: 6 months ] [ Designated as safety issue: No ]The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients
|Study Start Date:||December 2006|
|Study Completion Date:||February 2011|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
1000 mg/m2 over 100 minutes every 2 weeks.
Other Name: GemzarDrug: Bevacizumab
10 mg/kg every 2 weeks.
Other Name: AvastinDrug: Infusional 5-Fluorouracil
2400 mg/m2 over 48 hours every 2 weeks.
Rationale: Research indicates that the vascular endothelial growth factor (VEGF), or a substance made by cells that stimulates new blood vessel formation, plays an important role in the growth and metastasis of many cancers, including pancreatic carcinoma. Both VEGF and its receptors are overexpressed in pancreatic cancer. Bevacizumab works by blocking VEGF and the growth of cancer cells in the process. The current study combines bevacizumab with two commonly used pancreatic cancer drugs, gemcitabine and infusional 5-FU. Previous studies indicate that bevacizumab combined with other anti-cancer drugs such as 5-FU improves patient survival. In addition, other research suggests that the drug administration schedule of the current study may improve patient outcomes compared to other types of administration and sequencing.
Purpose: The primary objective of this study is to assess the rate of progression free survival at 6 months in patients with advanced pancreatic cancer given gemcitabine, infusional 5-FU, and bevacizumab. Secondary objectives of this study include measuring response rates, 6 month and 1-year survival rates, and median overall survival.
Treatment: Study participants will be given bevacizumab, gemcitabine, and 5-FU. These drugs will be administered through intravenous infusions in that order every other week on days 1 and 15. Treatments will be given in 28-day cycles. Participants will therefore receive study drugs during weeks 1 and 3, and then receive no study drugs during weeks 2 and 4. Imaging exams will be performed every 8 weeks to assess disease size. Several other tests will be given throughout the study to closely monitor patients. Tumor level markers will be assessed every 4 weeks, but will not be used to measure response. Study treatments will be discontinued due to disease growth or severe adverse effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417976
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|The Ohio State University James Cancer Hospital|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Tanios Saab, M.D.||Ohio State University|