NCT00028834

Brief Summary

This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2002

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

January 4, 2002

Last Update Submit

January 23, 2013

Conditions

Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage III Pancreatic CancerStage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (complete or partial responses)

    Up to 2 years

Secondary Outcomes (2)

  • Progression-free survival

    Up to 2 years

  • Overall survival

    Up to 2 years

Study Arms (1)

Treatment (gemcitabine hydrochloride, bevacizumab)

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochlorideBiological: bevacizumabOther: laboratory biomarker analysis

Interventions

gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (gemcitabine hydrochloride, bevacizumab)
bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (gemcitabine hydrochloride, bevacizumab)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gemcitabine hydrochloride, bevacizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Not amenable to curative treatment with surgery or radiotherapy
  • Locally advanced disease must extend outside the boundaries of a standard radiation port
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Pleural effusions and ascites not considered measurable lesions
  • No obvious tumor involvement of major vessels on CT scan
  • No known brain metastases
  • Performance status - ECOG 0-2
  • More than 3 months
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • No prior bleeding diathesis
  • Bilirubin normal
  • +41 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineBevacizumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hedy Kindler

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

December 1, 2004

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)