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

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ClinicalTrials.gov Identifier: NCT00417976
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : November 2, 2014
Last Update Posted : October 1, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Bevacizumab Drug: Infusional 5-Fluorouracil Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bevacizumab Drug: Gemcitabine
1000 mg/m2 over 100 minutes every 2 weeks.
Other Name: Gemzar

Drug: Bevacizumab
10 mg/kg every 2 weeks.
Other Name: Avastin

Drug: Infusional 5-Fluorouracil
2400 mg/m2 over 48 hours every 2 weeks.
Other Names:
  • Adrucil
  • Efudex
  • Fluoroplex


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Tony Bekaii-Saab
Genentech, Inc.
Investigators
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Principal Investigator: Tanios Saab, M.D. Ohio State University
More Information
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Additional Information:

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Responsible Party: Tony Bekaii-Saab, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00417976    
Other Study ID Numbers: OSU-05110
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
Keywords provided by Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center:
Advanced Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Bevacizumab
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors