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A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma

This study is not yet open for participant recruitment.
Verified by Gruppo Italiano MEsotelioma, October 2007

Sponsored by: Gruppo Italiano MEsotelioma
Information provided by: Gruppo Italiano MEsotelioma
ClinicalTrials.gov Identifier: NCT00551252
  Purpose

The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing either PDGFR-beta or C-kit


Condition Intervention Phase
Mesothelioma
Drug: Imatinib mesylate plus Gemcitabine
Phase II

MedlinePlus related topics:   Mesothelioma   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Imatinib    Imatinib mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   A Phase II Study of the Association of Glivec® (Imatinib Mesylate, Formerly Known as STI 571) Plus Gemzar® (Gemcitabine) in Patients With Unresectable, Refractory, Malignant Mesothelioma Expressing Either PDGFR-Beta or C-Kit

Further study details as provided by Gruppo Italiano MEsotelioma:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Every two months ]

Secondary Outcome Measures:
  • Progression-free-survival; Overall Survival; Safety [ Time Frame: Follow-up after end of treatment will be every three months; safety will be analyzed throughout the whole study ]

Estimated Enrollment:   56
Study Start Date:   January 2008
Estimated Study Completion Date:   December 2009

Arms Assigned Interventions
I: Experimental Drug: Imatinib mesylate plus Gemcitabine
Imatinib (400 mg daily) + Gemcitabine (500 mg/sqm, days 1 and 8 every 21 days) for a maximum of 6 cycles

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age of > 18 years and < 72 years
  • Patients with a histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing either PDFGR-beta or C-Kit by immunochemistry (ICH)
  • Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease
  • Confirmed progression of the disease according to modified REcist-criteria, documented after a first-line, systemic (premetrex+cisplatin regimen) or local treatment (i.e., intrapleuric)
  • ECOG Performance Status of 0, 1 or 2
  • Life expectancy of at least 3 months
  • Capability of understanding the objectives of the study and giving written informed consent
  • Willingness and ability to comply with study requirements
  • Sufficient caloric and fluid intake, including patients under enteral or parenteral nutrition

Exclusion Criteria:

  • Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma
  • A history of earlier tumors of different histologic origin being in complete remission since less than 5 years
  • Unresolved toxicity from prior antitumor treatment(s)
  • Primary peritoneal mesothelioma
  • Any of the following abnormal baseline hematological values:

    • Hb < 9 g/dL
    • WBC < 3 x 109/L
    • Neutrophils < 1.5 x 109/L
    • Platelets < 100 x 109/L
    • Serum bilirubin > 2.5 mg/dL
    • ALAT and ASAT > 3 x UNL (unless due to liver metastases)
    • Serum creatinine > 1.5 mg/dL
  • Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more
  • History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
  • Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
  • Uncontrolled active infections
  • Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551252

Contacts
Contact: Camillo Porta, MD     +39-0382-501355     c.porta@smatteo.pv.it    

Locations
Italy
Medical Oncology, IRCCS San Matteo University Hospital Foundation     Not yet recruiting
      Pavia, Italy, 27100
      Principal Investigator: Camillo Porta, MD            

Sponsors and Collaborators
Gruppo Italiano MEsotelioma

Investigators
Principal Investigator:     Camillo Porta, MD     Medical Oncology, IRCCS San Matteo University Hospital Foundation, pavia, Italy    
  More Information


Italian Mesothelioma Group Homepage  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   GIMe/01/06
First Received:   October 29, 2007
Last Updated:   October 29, 2007
ClinicalTrials.gov Identifier:   NCT00551252
Health Authority:   Italy: Ethics Committee

Study placed in the following topic categories:
Imatinib
Mesothelioma
Gemcitabine
Adenoma
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
Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 17, 2008




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