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A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Progression Free Survival at 6 months

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Tanios Saab, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

February 2011

Related Keywords:

  • Pancreatic Cancer
  • Advanced Pancreatic Cancer
  • Pancreatic Neoplasms



MetroHealth Medical CenterCleveland, Ohio  44109
Oncology/Hematology Care, Inc.Cincinnati, Ohio  45219
Mid Ohio Oncology Hematology, Inc.Columbus, Ohio  43222
University of CincinnatiCincinnati, Ohio  45267-0502
The Ohio State University James Cancer HospitalColumbus, Ohio  43210
The University of MichiganAnn Arbor, Michigan  48109
Oncology Partners Network, Ltd.Cincinnati, Ohio  45238