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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 3, 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

Tracking Information
First Submitted Date  ICMJE January 2, 2007
First Posted Date  ICMJE January 4, 2007
Results First Submitted Date  ICMJE May 19, 2014
Results First Posted Date  ICMJE November 3, 2014
Last Update Posted Date October 1, 2015
Study Start Date  ICMJE December 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2007)
Rate of Progression Free Survival at 6 months
Change History Complete list of historical versions of study NCT00417976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2007)
Response rate, 6 months and 1 year survival rate, and median overall survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
Official Title  ICMJE A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Bevacizumab
Interventions:
  • Drug: Gemcitabine
  • Drug: Bevacizumab
  • Drug: Infusional 5-Fluorouracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2014)
42
Original Enrollment  ICMJE
 (submitted: January 3, 2007)
39
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00417976
Other Study ID Numbers  ICMJE OSU-05110
NCI-2011-03230 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Tony Bekaii-Saab
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Tanios Saab, M.D. Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP