Gemcitabine/Abraxane Chemotherapy And Dose Escalated Radiotherapy For Locally Advanced, Unresectable Pancreatic Cancer

Study Overview

Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer

This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.

The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.

Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Abraxane
RADIATION: Radiation Therapy

UCC-GI-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-09-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-10-23
First Submitted that Met QC Criteria 2012-09-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-10-26
First Posted (ESTIMATED) 2012-09-26	Results First Posted N/A	Last Verified 2015-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemzar/Abraxane and Radiation Therapy Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine	DRUG: Gemcitabine gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT. Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks. DRUG: Abraxane Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT RADIATION: Radiation Therapy IMRT Dose escalation: 60 Gy (2 Gy/fraction)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemzar/Abraxane and Radiation Therapy

Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine

DRUG: Gemcitabine

gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT. Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks.

DRUG: Abraxane

Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT

RADIATION: Radiation Therapy

IMRT Dose escalation: 60 Gy (2 Gy/fraction)

Primary Outcome Measures	Measure Description	Time Frame
Increase overall survival	Estimated increase in median survival from 11 to 16 months	23 months

Secondary Outcome Measures	Measure Description	Time Frame
Rate of local control	Determine rate of local control from the date of start of treatment to the date of the time of local progression	baseline to average up to 24 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically proven carcinoma of the pancreas that is locally advanced
ECOG performance status 0- 2
Adequate labs
No prior abdominal radiation therapy
No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
All disease must be encompassed within a radiotherapy portal
Not pregnant or nursing

Patient has metastatic disease on radiological staging
systemic therapy.
Patient has known active infection with HIV, hepatitis C or hepatitis B
Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
Patient is deemed to be have obvious resectable disease at presentation
Received any investigational agent within a month prior to enrollment.
Neuroendocrine tumors of the pancreas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Olugbenga Olowokure, MD, University of Cincinnati

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record