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

NCT00417976 | Completed Phase 2 Results DMC

• 2 other identifiers: OSU-05110NCI-2011-03230
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy

  6 months

Secondary Outcomes (1)

• Response Rates Defined by RECIST 1.0

  6 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Drug: Gemcitabine; Drug: Bevacizumab; Drug: Infusional 5-Fluorouracil

Interventions

Gemcitabine DRUG

1000 mg/m2 over 100 minutes every 2 weeks.

Also known as: Gemzar

Bevacizumab

Bevacizumab DRUG

10 mg/kg every 2 weeks.

Also known as: Avastin

Bevacizumab

Infusional 5-Fluorouracil DRUG

2400 mg/m2 over 48 hours every 2 weeks.

Also known as: Adrucil, Efudex, Fluoroplex

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age \>=18 years.
• Established histological confirmation of adenocarcinoma of the pancreas.
• Stage III and stage IV will be allowed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tony Bekaii-Saab: lead
• Genentech, Inc.: collaborator

Study Sites (2)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

The Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Bevacizumab; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones

Limitations and Caveats

42 patients enrolled, 39 were evaluable for the primary end point.

Results Point of Contact

• Title: Tanios Bekaii-Saab
• Organization: The Ohio State University

Tanios.saab@osumc.edu

614-293-9863

Study Officials

• Tanios Saab, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: December 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: February 1, 2011
• Last Updated: October 1, 2015
• Results First Posted: November 3, 2014

Record last verified: 2015-09

Locations

US (2)