Overview

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