Paclitaxel In Treating Patients With Unresectable Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic 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.

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.

Pancreatic Cancer

DRUG: paclitaxel-loaded polymeric micelle

CDR0000433513
TARGET-S04-10485
WIRB-20050099

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-05-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-12-13
First Submitted that Met QC Criteria 2005-05-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-12-14
First Posted (ESTIMATED) 2005-05-27	Results First Posted N/A	Last Verified 2009-06

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-1

Not specified

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

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

Creatinine ≤ 1.5 times ULN

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

Not specified

No prior chemotherapy for pancreatic cancer

Prior fluorouracil as a radiosensitizer allowed

Not specified

More than 6 weeks since prior radiotherapy for pancreatic cancer

Disease must have progressed after completion of radiotherapy

More than 14 days since prior major surgery and recovered

More than 30 days since prior investigational agents

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: John S. MacDonald, MD, Beth Israel Comprehensive Cancer Center - West Side Campus

Publications

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

General Publications

Saif MW, Podoltsev NA, Rubin MS, Figueroa JA, Lee MY, Kwon J, Rowen E, Yu J, Kerr RO. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest. 2010 Feb;28(2):186-94. doi: 10.3109/07357900903179591.

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