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

This study is currently recruiting participants.
Verified September 2012 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Olugbenga Olowokure, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01693276
First received: September 19, 2012
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: Gemcitabine
Drug: Abraxane
Radiation: Radiation Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Increase overall survival [ Time Frame: 23 months ] [ Designated as safety issue: No ]
    Estimated increase in median survival from 11 to 16 months


Secondary Outcome Measures:
  • Rate of local control [ Time Frame: baseline to average up to 24 weeks ] [ Designated as safety issue: No ]
    Determine rate of local control from the date of start of treatment to the date of the time of local progression


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: nab-Paclitaxel
Radiation: Radiation Therapy
IMRT Dose escalation: 60 Gy (2 Gy/fraction)
Other Name: RT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693276

Contacts
Contact: UC Cancer Institute 513-584-7698

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UC Cancer Institute     513-584-7698        
Principal Investigator: Olugbenga Olowokure, MD            
Principal Investigator: Michelle Mierzwa, MD            
Sponsors and Collaborators
Olugbenga Olowokure
Investigators
Principal Investigator: Olugbenga Olowokure, MD University of Cincinnati
Principal Investigator: Michelle Mierzwa, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Olugbenga Olowokure, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01693276     History of Changes
Other Study ID Numbers: UCC-GI-01
Study First Received: September 19, 2012
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013