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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00111904
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : December 14, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: paclitaxel-loaded polymeric micelle Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer
Study Start Date : May 2005
Primary Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Time to progression
  2. Time to treatment failure
  3. Best overall response rate
  4. Overall survival
  5. Clinical benefit
  6. Safety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111904


Locations
United States, Florida
Florida Cancer Specialists - Bonita Springs
Bonita Springs, Florida, United States, 34135
United States, Illinois
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
United States, Louisiana
Louisiana Oncology Associates - Lafayette
Lafayette, Louisiana, United States, 70506
United States, New York
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States, 10011
United States, Texas
Southwest Regional Cancer Center - Central
Austin, Texas, United States, 78705
Sponsors and Collaborators
Theradex
Investigators
Study Chair: John S. MacDonald, MD Beth Israel Comprehensive Cancer Center - West Side Campus
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00111904     History of Changes
Other Study ID Numbers: CDR0000433513
TARGET-S04-10485
WIRB-20050099
First Posted: May 27, 2005    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: June 2009

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action