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

NCT ID: NCT01693276

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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.

Abraxane

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

IMRT Dose escalation: 60 Gy (2 Gy/fraction)

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Radiation Therapy

IMRT Dose escalation: 60 Gy (2 Gy/fraction)

Intervention Type: RADIATION

Other Intervention Names

Gemzar; nab-Paclitaxel; RT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olugbenga Olowokure

OTHER

Sponsor Role: lead

Responsible Party

Olugbenga Olowokure

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olugbenga Olowokure, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Michelle Mierzwa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

UCC-GI-01

Identifier Type: -

Identifier Source: org_study_id