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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Imatinib Imatinib mesylate

U.S. FDA Resources

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

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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
Pavia, Italy, 27100

Sponsors and Collaborators

Gruppo Italiano MEsotelioma

Investigators

Principal Investigator:

Camillo Porta, MD

Medical Oncology, IRCCS San Matteo University Hospital Foundation, pavia, Italy

More Information

Additional Information:

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

Publications:

Bertino P, Porta C, Barbone D, Germano S, Busacca S, Pinato S, Tassi G, Favoni R, Gaudino G, Mutti L. Preliminary data suggestive of a novel translational approach to mesothelioma treatment: imatinib mesylate with gemcitabine or pemetrexed. Thorax. 2007 Aug;62(8):690-5. Epub 2007 Feb 20.

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

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

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Imatinib
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Gemcitabine
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009