NCT00095966

Brief Summary

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic pancreatic cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

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

Study Start

First participant enrolled

September 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

November 9, 2004

Last Update Submit

July 1, 2013

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Response rate as measured by RECIST criteria

    Up to 6 months

Secondary Outcomes (3)

  • Progression free survival

    From start of treatment to progression or death, assessed up to 6 months

  • Survival

    At 6 months

  • Overall survival

    Up to 6 months

Study Arms (1)

Treatment (sorafenib tosylate and gemcitabine hydrochloride)

EXPERIMENTAL

Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: sorafenib tosylateDrug: gemcitabine hydrochloride

Interventions

sorafenib tosylateDRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate and gemcitabine hydrochloride)
gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (sorafenib tosylate and gemcitabine hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Locally advanced or metastatic disease
  • Locally advanced disease must extend outside the boundaries of a standard radiotherapy port
  • Not amenable to curative surgery or radiotherapy
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Pleural effusion and ascites are not considered measurable lesions
  • Outside prior radiotherapy port
  • No known brain metastases
  • Performance status - ECOG 0-1
  • Performance status - Karnofsky 70-100%
  • More than 3 months
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • +34 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

SorafenibGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

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

November 9, 2004

First Posted

November 9, 2004

Study Start

September 1, 2004

Primary Completion

September 1, 2005

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)