Status:
COMPLETED
Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Mesothelioma, Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age of \> 18 years.
- Histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing PDGFR-beta and/or C-kit by immunohistochemistry.
- Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease.
- Confirmed progression of the disease according to modified RECIST-criteria, documented after a pemetrexed-based chemotherapy.
- Eastern Cooperative Oncology group (ECOG) Performance Status of 0, 1 or 2.
- Life expectancy of at least 3 months.
- Written informed consent.
Exclusion
- 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 for 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
- White blood count (WBC) \< 3 x 109/L
- Neutrophils \< 1.5 x 109/L
- Platelets \< 100 x 109/L
- Serum bilirubin \> 2.5 mg/dL
- Alanine transaminase (ALAT) and Aspartate transaminase (ASAT) \> 3 x upper normal limit (UNL) (unless due to liver metastases)
- Serum creatinine \> 1.5 mg/dL.
- Symptomatic and/or unstable pre-existing brain metastases. To be enrolled in the study, subjects must have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have central nervous system (CNS) metastases well controlled by steroids, anti - epileptics or other symptom-relieving medications.
- 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 New York Heart Association (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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02303899
Start Date
November 1 2014
End Date
December 1 2017
Last Update
January 22 2021
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089