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

NCT01693276 | Terminated Phase 1

• 1 other identifier: UCC-GI-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Increase overall survival

  Estimated increase in median survival from 11 to 16 months

  23 months

Secondary Outcomes (1)

• Rate of local control

  baseline to average up to 24 weeks

Study Arms (1)

Gemzar/Abraxane and Radiation Therapy

EXPERIMENTAL

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.

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

Interventions

Gemcitabine 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.

Also known as: Gemzar

Gemzar/Abraxane and Radiation Therapy

Abraxane 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

Also known as: nab-Paclitaxel

Gemzar/Abraxane and Radiation Therapy

Radiation Therapy RADIATION

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

Also known as: RT

Gemzar/Abraxane and Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olugbenga Olowokure: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• Olugbenga Olowokure, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Michelle Mierzwa, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (1)