Clincosm LogoSign in Get a demo

DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

Sponsor
Theradex (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00024375
Collaborator
(none)
9
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with DHA-paclitaxel.

  • Determine the overall survival of patients treated with this drug.

  • Determine the toxicity profile of this drug in these patients.

  • Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses, and at completion of treatment.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas
Study Start Date :
Jun 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically or cytologically confirmed carcinoma of the pancreas

    • Metastatic disease

    • Measurable disease

    • Lesions within a previously irradiated field are not considered measurable

    • No islet cell tumors, lymphoma, or sarcoma of the pancreas

    • 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 at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

    • SGOT or SGPT no greater than 2.5 times ULN

    Renal:
    • Creatinine no greater than 1.5 times ULN
    Cardiovascular:

    • No uncontrolled ventricular arrhythmia

    • No myocardial infarction within the past 3 months

    • No superior vena cava syndrome

    Neurologic:

    • No peripheral neuropathy greater than grade 1

    • No uncontrolled major seizure disorder

    • No spinal cord compression

    Other:

    • No concurrent serious infection requiring parenteral therapy

    • No unstable or serious concurrent medical condition

    • No other prior malignancy except:

    • Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR

    • Other cancer curatively treated with surgery alone that has not recurred for more than 5 years

    • No psychiatric disorder that would preclude study compliance

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 6 months after study therapy

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No concurrent immunotherapy
    Chemotherapy:

    • No prior chemotherapy for metastatic disease

    • Prior adjuvant chemoradiotherapy allowed

    • At least 28 days since prior chemotherapy and recovered

    • No other concurrent chemotherapy

    Endocrine therapy:
    • No concurrent hormonal therapy except megestrol
    Radiotherapy:

    • See Disease Characteristics

    • Prior adjuvant chemoradiotherapy allowed

    • At least 28 days since prior large-field radiotherapy and recovered

    • No concurrent radiotherapy

    Surgery:
    • At least 14 days since prior major surgery and recovered
    Other:
    • No other concurrent anticancer therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    2 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    3 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    4 Virginia Mason Medical Center Seattle Washington United States 98101
    5 Kliniken Essen - Mitte Essen Germany D-45136
    6 Krankenhaus Nordwest Frankfurt Germany D-60488
    7 Erasmus Medical Center Rotterdam Netherlands 3008 EA
    8 New Cross Hospital Wolverhampton England United Kingdom WV10 0QP
    9 Beatson Oncology Centre Glasgow Scotland United Kingdom G11 6NT

    Sponsors and Collaborators

    • Theradex

    Investigators

    • Study Chair: Ross C. Donehower, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00024375
    Other Study ID Numbers:
    • CDR0000068926
    • THERADEX-P01-00-03
    • PROTARGA-P01-00-03
    • VMRC-8770
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Feb 18, 2009
    Last Verified:
    Mar 1, 2003
    Keywords provided by , ,
    recurrent pancreatic cancer
    stage IV pancreatic cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Feb 18, 2009