Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417976
• Other study ID #: OSU-05110
• Secondary ID: NCI-2011-03230
• Status: Completed
• Phase: Phase 2
• First received: January 2, 2007
• Last updated: September 15, 2015
• Start date: December 2006
• Est. completion date: February 2011

Study information

• Verified date: September 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females age >=18 years.

• Established histological confirmation of adenocarcinoma of the pancreas.

• Stage III and stage IV will be allowed.

Exclusion Criteria:

• No prior chemotherapy or radiotherapy allowed except for that given as part of an adjuvant regimen if >4 weeks have elapsed since the end of therapy. Any prior treatment with antibodies to VEGF.

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting the study.

• Pregnant or lactating women.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
1000 mg/m2 over 100 minutes every 2 weeks.
• Bevacizumab
10 mg/kg every 2 weeks.
• Infusional 5-Fluorouracil
2400 mg/m2 over 48 hours every 2 weeks.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan
United States	The Ohio State University James Cancer Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Tony Bekaii-Saab	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy		6 months	No
Secondary	Response Rates Defined by RECIST 1.0	The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients	6 months	No

External Links

•   Jamesline