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

Phase 1

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Gemcitabine; Drug: Abraxane; Radiation: Radiation Therapy

• Registration Number: NCT01693276
• Lead Sponsor: Olugbenga Olowokure

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemzar/Abraxane and Radiation Therapy	Abraxane	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.
Gemzar/Abraxane and Radiation Therapy	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.
Gemzar/Abraxane and Radiation Therapy	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Increase overall survival	23 months	Estimated increase in median survival from 11 to 16 months

Secondary Outcome Measures

Name	Time	Method
Rate of local control	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

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States