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Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT

NCT00761241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-05-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gemcitabine, Docetaxel, 5FU, Oxaliplatin

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

BIOLOGICAL

Alpha-interferon

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

RADIATION

Abdominal/pelvic radiation therapy

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

PROCEDURE

Pancreaticoduodenectomy

Surgery performed if subject is considered candidate by protocol definition.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Benaroya Research Institute

    lead OTHER

Principal Investigators

  • Vincent Picozzi, MD · Virginia Mason Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-03-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00761241 on ClinicalTrials.gov