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

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olugbenga Olowokure
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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