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Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

This study has been completed.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017186
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.


Condition Intervention Phase
Malignant Mesothelioma
Drug: epirubicin hydrochloride
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Mesothelioma   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Epirubicin hydrochloride    Epirubicin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma

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

Study Start Date:   July 2001
Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma.
  • Determine the toxicity of this regimen in this patient population.
  • Determine the time to progression and overall survival of patients treated with this regimen.
  • Assess quality of life in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.

Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 15-41 patients will be accrued for this study within 6-18 months.

  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 malignant pleural mesothelioma
  • At least 1 measurable lesion that can be accurately measured in at least one dimension

    • At least 20 mm (2 cm) in diameter

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

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)
  • AST no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • LVEF at least 50%
  • No history of congestive heart failure
  • No New York Heart Association class III or IV heart disease

Other:

  • No uncontrolled infection
  • No other severe underlying disease that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
  • No prior gemcitabine or anthracyclines

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent cimetidine
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017186

Show 24 study locations  Show 24 Study Locations

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Scott Okuno, MD     Mayo Clinic    
  More Information


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

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000068659, NCCTG-N0021
First Received:   June 6, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00017186
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma  
advanced malignant mesothelioma  
recurrent malignant mesothelioma  

Study placed in the following topic categories:
Mesothelioma
Gemcitabine
Epirubicin
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 06, 2008




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