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DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Theradex
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024375
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: DHA-paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

Drug Information available for:   Paclitaxel    DHA-paclitaxel    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

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

Study Start Date:   June 2001

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.

  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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024375

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins    
      Baltimore, Maryland, United States, 21231-2410
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center    
      New York, New York, United States, 10016
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia    
      Philadelphia, Pennsylvania, United States, 19107-5541
United States, Washington
Virginia Mason Medical Center    
      Seattle, Washington, United States, 98101
Germany
Kliniken Essen - Mitte    
      Essen, Germany, D-45136
Krankenhaus Nordwest    
      Frankfurt, Germany, D-60488
Netherlands
Erasmus Medical Center    
      Rotterdam, Netherlands, 3008 EA
United Kingdom, England
New Cross Hospital    
      Wolverhampton, England, United Kingdom, WV10 0QP
United Kingdom, Scotland
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    
  More Information


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

Study ID Numbers:   CDR0000068926, THERADEX-P01-00-03, PROTARGA-P01-00-03, VMRC-8770
First Received:   September 13, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00024375
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Paclitaxel
Pancreatic Neoplasms
Neoplasm Metastasis
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Pancrelipase
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 December 03, 2008




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