Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Overview[ - collapse ][ - ]
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. |
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Condition | Pancreatic Cancer |
Intervention | Drug: Gemcitabine Drug: Abraxane Radiation: Radiation Therapy |
Phase | Phase 1/Phase 2 |
Sponsor | Olugbenga Olowokure |
Responsible Party | University of Cincinnati |
ClinicalTrials.gov Identifier | NCT01693276 |
First Received | September 19, 2012 |
Last Updated | October 23, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 19, 2012 |
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Last Updated Date | October 23, 2013 |
Start Date | September 2012 |
Estimated Primary Completion Date | March 2020 |
Current 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 |
Current 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 |
Descriptive Information[ + expand ][ + ]
Brief Title | Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer |
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Official Title | Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer |
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. |
Study Type | Interventional |
Study Phase | Phase 1/Phase 2 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Pancreatic Cancer |
Intervention | 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: GemzarDrug: 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-PaclitaxelRadiation: Radiation Therapy IMRT Dose escalation: 60 Gy (2 Gy/fraction) Other Names: RT |
Study Arm (s) | 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. |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 50 |
Estimated Completion Date | March 2020 |
Estimated Primary Completion Date | March 2017 |
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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: UC Cancer Institute 513-584-7698 |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01693276 |
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Other Study ID Numbers | UCC-GI-01 |
Has Data Monitoring Committee | No |
Information Provided By | University of Cincinnati |
Study Sponsor | Olugbenga Olowokure |
Collaborators | Not Provided |
Investigators | Principal Investigator: Olugbenga Olowokure, MD University of CincinnatiPrincipal Investigator: Michelle Mierzwa, MD University of Cincinnati |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
University of Cincinnati | Cincinnati, Ohio, United States, 45219 Contact: UC Cancer Institute | 513-584-7698Principal Investigator: Olugbenga Olowokure, MD Recruiting |
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