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.
ConditionPancreatic Cancer
InterventionDrug: Gemcitabine
Drug: Abraxane
Radiation: Radiation Therapy
PhasePhase 1/Phase 2
SponsorOlugbenga Olowokure
Responsible PartyUniversity of Cincinnati
ClinicalTrials.gov IdentifierNCT01693276
First ReceivedSeptember 19, 2012
Last UpdatedOctober 23, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateSeptember 19, 2012
Last Updated DateOctober 23, 2013
Start DateSeptember 2012
Estimated Primary Completion DateMarch 2020
Current Primary Outcome MeasuresIncrease overall survival [Time Frame: 23 months] [Designated as safety issue: No]Estimated increase in median survival from 11 to 16 months
Current Secondary Outcome MeasuresRate 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 TitleGemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Official TitleGemcitabine/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 TypeInterventional
Study PhasePhase 1/Phase 2
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionPancreatic Cancer
InterventionDrug: 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 StatusRecruiting
Estimated Enrollment50
Estimated Completion DateMarch 2020
Estimated Primary Completion DateMarch 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: UC Cancer Institute
513-584-7698
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01693276
Other Study ID NumbersUCC-GI-01
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Cincinnati
Study SponsorOlugbenga Olowokure
CollaboratorsNot Provided
Investigators Principal Investigator: Olugbenga Olowokure, MD University of CincinnatiPrincipal Investigator: Michelle Mierzwa, MD University of Cincinnati
Verification DateOctober 2013

Locations[ + expand ][ + ]

University of Cincinnati
Cincinnati, Ohio, United States, 45219
Contact: UC Cancer Institute | 513-584-7698
Principal Investigator: Olugbenga Olowokure, MD
Recruiting