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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693276
Recruitment Status : Terminated (Slow accrual)
First Posted : September 26, 2012
Last Update Posted : October 26, 2015
Information provided by (Responsible Party):
Olugbenga Olowokure, University of Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Abraxane Radiation: Radiation Therapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Study Start Date : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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 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

Primary Outcome Measures :
  1. Increase overall survival [ Time Frame: 23 months ]
    Estimated increase in median survival from 11 to 16 months

Secondary Outcome Measures :
  1. Rate of local control [ Time Frame: baseline to average up to 24 weeks ]
    Determine rate of local control from the date of start of treatment to the date of the time of local progression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693276

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Olugbenga Olowokure
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Principal Investigator: Olugbenga Olowokure, MD University of Cincinnati
Principal Investigator: Michelle Mierzwa, MD University of Cincinnati
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Responsible Party: Olugbenga Olowokure, Assistant Professor, University of Cincinnati Identifier: NCT01693276    
Other Study ID Numbers: UCC-GI-01
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015
Keywords provided by Olugbenga Olowokure, University of Cincinnati:
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs