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Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2007
Sponsored by: Theradex
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00111904
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: paclitaxel-loaded polymeric micelle
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Best overall response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Clinical benefit [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111904

Locations
United States, Florida
Florida Cancer Specialists - Bonita Springs Recruiting
Bonita Springs, Florida, United States, 34135
Contact: Clinical Trials Office - Florida Cancer Specialists - Bonita S     239-274-9930        
United States, Illinois
Midwest Cancer Research Group, Incorporated Recruiting
Skokie, Illinois, United States, 60077
Contact: K. Joseph Phillip     847-673-1999     ggolden@cancerstudy.com    
United States, Louisiana
Louisiana Oncology Associates - Lafayette Recruiting
Lafayette, Louisiana, United States, 70506
Contact: David A. Rinaldi, MD     337-235-7898     davrinald@hotmail.com    
United States, New York
St. Vincent's Comprehensive Cancer Center - Manhattan Recruiting
New York, New York, United States, 10011
Contact: Clinical Trials Office - St. Vincent's Comprehensive Cancer Ce     212-367-1729        
United States, Texas
Southwest Regional Cancer Center - Central Recruiting
Austin, Texas, United States, 78705
Contact: Robert O. Kerr, MD     512-421-4141     RKerr@swrcc.com    
Sponsors and Collaborators
Theradex
Investigators
Study Chair: John S. MacDonald, MD St. Vincent's Comprehensive Cancer Center - Manhattan
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000433513, THERADEX-S04-10485, WIRB-20050099
Study First Received: May 26, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00111904  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Paclitaxel
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009