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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01693276
• Other study ID #: UCC-GI-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 19, 2012
• Last updated: October 23, 2015
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

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.
• 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

Radiation:
• Radiation Therapy
IMRT Dose escalation: 60 Gy (2 Gy/fraction)

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Olugbenga Olowokure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase overall survival	Estimated increase in median survival from 11 to 16 months	23 months	No
Secondary	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	baseline to average up to 24 weeks	No