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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Abraxane; Radiation: Radiation Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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 and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.

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.; Other Names: Gemzar; 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; Other Names: nab-Paclitaxel; Radiation: Radiation Therapy; IMRT Dose escalation: 60 Gy (2 Gy/fraction); Other Names: RT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Olugbenga Olowokure
• Investigators: Principal Investigator: Olugbenga Olowokure, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: UCC-GI-01