This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient refusal or withdrawal of patient consent, or unacceptable toxicity
Pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by IHC will receive chemotherapy as follow : * Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule; * Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule. Treatment repeats every 21 days in the absence of disease progression, patient refusal or withdrawal of patient consent, or unacceptable toxicity. The molecular profile of patients enrolled will be evaluated with Ion Personal Genome Machine (PGM) Torrent Next-generation Sequencing platform in order to individuate potential predictive biomarkers and to improve the understanding of the molecular biology of these rare tumors. A correlation among the molecular profiles identified, clinical characteristics, and survival data of patients will be done
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
infusion drug
oral drug
Istituto Clinico Humanitas
Rozzano, MI, Italy
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine
assess the anti-tumor activity of Imatinib mesylate in combination with Gemcitabine, in terms of 3-months progression-free survival (PFS) rate
Time frame: 12 weeks
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of Response Evaluation Criteria In Solid Tumors (RECIST) criteria
assess anti-tumor activity of Imatinib Mesylate (IM) in combination with GEM, in terms of objective response rate according to RECIST criteria (Modified RECIST criteria for MPM), and duration of response
Time frame: 16 weeks
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of overall survival (OS).
assess anti-tumor activity of IM in combination with GEM, in terms of overall survival (OS).
Time frame: 30 months
safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
determine the safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
Time frame: 16 weeks
molecular profile of patients
evaluate the molecular profile of patients enrolled with Ion PGM Torrent Next-generation Sequencing platform correlating the molecular profiles identified with clinical characteristics and survival data of patients.
Time frame: baseline
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