NCT00761241

Brief Summary

This study is being conducted to find out what effects (good and bad) that a combination of treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery can be performed. Current treatments for this stage of pancreas cancer offer less than ideal results, with little opportunity for treatment with curative intent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2 pancreatic-cancer

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, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 26, 2010

Status Verified

May 1, 2010

Enrollment Period

1.5 years

First QC Date

September 25, 2008

Last Update Submit

May 25, 2010

Conditions

Pancreatic Cancer

Keywords

pancreas cancercombined modality therapy

Outcome Measures

Primary Outcomes (1)

  • Two year overall survival

    two years

Secondary Outcomes (1)

  • median disease free survival initial response rate to gemcitabine/docetaxel (tumor marker and radiographic) toxicity of overall regimen time to disease progression percentage of patients able to complete protocol to entirety

    two years

Interventions

Gemcitabine, Docetaxel, 5FU, OxaliplatinDRUG

Gemcitabine: 1000 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8cycles Docetaxel: 40 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8 cycles Gemcitabine/docetaxel will be repeated (based upon initial response) Oxaliplatin: 40 mg/m2 IV on day 1 of each week of radiation 5-FU: 175 mg/m2 continuous infusion on days 1-18 and 29-46 of radiation

Alpha-interferonBIOLOGICAL

Alpha-interferon: injected subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 29, 31, 33, 36, 38, 40, 43 and 46 during radiation therapy

Abdominal/pelvic radiation therapyRADIATION

3-D conformal technique. The dose per fraction will be 180cGy, with a total dose of 5040 cGy in 28 fractions. Radiation therapy will be delivered on days 1-18 and days 29-46

PancreaticoduodenectomyPROCEDURE

Surgery performed if subject is considered candidate by protocol definition.

Eligibility Criteria

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

You may qualify if:

  • Biopsy proven adenocarcinoma of the pancreas
  • Tumor must be radiographically bidimensional by abdominal/pelvic CT
  • Cancer must be locally advanced and not considered immediately treated by standard surgical procedure
  • No prior therapy for pancreas cancer

You may not qualify if:

  • Women who are pregnant or lactating
  • Subjects who have received prior external beam radiation to the abdomen or pelvis
  • Subjects receiving chronic immunosuppressive therapy (prednisone, methotrexate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineDocetaxelFluorouracilOxaliplatinInterferon-alphaPancreaticoduodenectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesCoordination ComplexesInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Vincent Picozzi, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

May 26, 2010

Record last verified: 2010-05

Locations

US(1)