- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417976
Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- The University of Michigan
-
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University James Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bevacizumab
|
1000 mg/m2 over 100 minutes every 2 weeks.
Other Names:
10 mg/kg every 2 weeks.
Other Names:
2400 mg/m2 over 48 hours every 2 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Fluorouracil
- Bevacizumab
Other Study ID Numbers
- OSU-05110
- NCI-2011-03230 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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