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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Gruppo Italiano MEsotelioma.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Gruppo Italiano MEsotelioma
ClinicalTrials.gov Identifier:
NCT00551252
First received: October 29, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: I 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Imatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014