Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00417976|
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : November 2, 2014
Last Update Posted : October 1, 2015
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Bevacizumab Drug: Infusional 5-Fluorouracil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||February 2011|
1000 mg/m2 over 100 minutes every 2 weeks.
Other Name: Gemzar
10 mg/kg every 2 weeks.
Other Name: Avastin
Drug: Infusional 5-Fluorouracil
2400 mg/m2 over 48 hours every 2 weeks.
- Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy [ Time Frame: 6 months ]
- Response Rates Defined by RECIST 1.0 [ Time Frame: 6 months ]The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males or females age >=18 years.
- Established histological confirmation of adenocarcinoma of the pancreas.
- Stage III and stage IV will be allowed.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Responsible Party:||Tony Bekaii-Saab, Principal Investigator, Ohio State University Comprehensive Cancer Center|
|Other Study ID Numbers:||
NCI-2011-03230 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
|First Posted:||January 4, 2007 Key Record Dates|
|Results First Posted:||November 2, 2014|
|Last Update Posted:||October 1, 2015|
|Last Verified:||September 2015|
Advanced Pancreatic Cancer
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents, Immunological
Angiogenesis Modulating Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action