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

NCT ID: NCT00417976

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2011-02-28

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumab

Intervention Type: DRUG

10 mg/kg every 2 weeks.

Infusional 5-Fluorouracil

Intervention Type: DRUG

2400 mg/m2 over 48 hours every 2 weeks.

Interventions

Gemcitabine

1000 mg/m2 over 100 minutes every 2 weeks.

Intervention Type: DRUG

Bevacizumab

10 mg/kg every 2 weeks.

Intervention Type: DRUG

Infusional 5-Fluorouracil

2400 mg/m2 over 48 hours every 2 weeks.

Intervention Type: DRUG

Other Intervention Names

Gemzar; Avastin; Adrucil; Efudex; Fluoroplex

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Tony Bekaii-Saab

OTHER

Sponsor Role: lead

Responsible Party

Tony Bekaii-Saab

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tanios Saab, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The University of Michigan

Ann Arbor, Michigan, United States

The Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

NCI-2011-03230

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-05110

Identifier Type: -

Identifier Source: org_study_id