Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

December 13, 2011 updated by: Theradex

Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
  • Determine the best overall response rate and duration of response in patients treated with this drug.
  • Determine the overall survival of patients treated with this drug.
  • Determine the clinical benefit and safety of this drug in these patients.

OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bonita Springs, Florida, United States, 34135
        • Florida Cancer Specialists - Bonita Springs
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group, Incorporated
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Louisiana Oncology Associates - Lafayette
    • New York
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center - Manhattan
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center - Central

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed epithelial carcinoma of the pancreas

    • Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
  • No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
  • No unstable or serious medical condition
  • No psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for pancreatic cancer

    • Prior fluorouracil as a radiosensitizer allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 6 weeks since prior radiotherapy for pancreatic cancer

    • Disease must have progressed after completion of radiotherapy

Surgery

  • More than 14 days since prior major surgery and recovered

Other

  • More than 30 days since prior investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to progression
Time to treatment failure
Overall survival
Safety
Clinical benefit
Best overall response rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theradex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 26, 2005

First Submitted That Met QC Criteria

May 26, 2005

First Posted (Estimate)

May 27, 2005

Study Record Updates

Last Update Posted (Estimate)

December 14, 2011

Last Update Submitted That Met QC Criteria

December 13, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000433513
  • TARGET-S04-10485
  • WIRB-20050099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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