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

Olugbenga Olowokure

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Radiation: Radiation Therapy; Drug: Abraxane

Study type: Interventional

Funder types: Other

Identifiers

NCT01693276

UCC-GI-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Gemzar/Abraxane and Radiation Therapy

Experimental group

Description:

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.

Treatment:

Drug: Abraxane

Radiation: Radiation Therapy

Drug: Gemcitabine