Back to resultsGemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Abraxane
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer
Eligibility 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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemzar/Abraxane and Radiation Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Increase overall survival
Estimated increase in median survival from 11 to 16 months
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01693276
First Posted
September 19, 2012
Last Updated
October 23, 2015
Sponsor
Olugbenga Olowokure
1. Study Identification
Unique Protocol Identification Number
NCT01693276
Brief Title
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Official Title
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olugbenga Olowokure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemzar/Abraxane and Radiation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Abraxane
Other Intervention Name(s)
nab-Paclitaxel
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
RT
Intervention Description
IMRT Dose escalation: 60 Gy (2 Gy/fraction)
Primary Outcome Measure Information:
Title
Increase overall survival
Description
Estimated increase in median survival from 11 to 16 months
Time Frame
23 months
Secondary Outcome Measure Information:
Title
Rate of local control
Description
Determine rate of local control from the date of start of treatment to the date of the time of local progression
Time Frame
baseline to average up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olugbenga Olowokure, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Mierzwa, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
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