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Status:

COMPLETED

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

Lead Sponsor:

Theradex

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    43 Patients enrolled

    Trial Details

    Trial ID

    NCT00111904

    Start Date

    May 1 2005

    Last Update

    December 14 2011

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Florida Cancer Specialists - Bonita Springs

    Bonita Springs, Florida, United States, 34135

    2

    Midwest Cancer Research Group, Incorporated

    Skokie, Illinois, United States, 60077

    3

    Louisiana Oncology Associates - Lafayette

    Lafayette, Louisiana, United States, 70506

    4

    St. Vincent's Comprehensive Cancer Center - Manhattan

    New York, New York, United States, 10011