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

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano MEsotelioma
• Treatments: Gemcitabine; Imatinib Mesylate

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