Malignant Pleural Mesothelioma Clinical Trial
Official title:
"Phase II Study: Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma "
Liposomal doxorubicin consists on doxorubicin encapsulated in liposomes that are composed of
phosphatidylcholine and cholesterol. Liposomal doxorubicin can extravasate into tumors with
abnormal vascular endothelium but may not penetrate normal tissues lowering its toxicity and
increasing its efficiency. Combining Liposomal doxorubicin with cisplatin could be an
effective new chemotherapy treatment for malignant pleural mesothelioma .
Hypothesis:
Liposomal doxorubicin combined with cisplatin could increase response rates to chemotherapy,
progression free survival and overall survival in patients with malignant pleural
mesothelioma.
Status | Active, not recruiting |
Enrollment | 31 |
Est. completion date | June 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM from the Instituto Nacional de Cancerología and the Instituto Nacional de Enfermedades Respiratorias - ECOG functional status 0 or 2 - No renal function alteration (GFR >50%) - No hepatic function alteration - Leucocytes more than 2,000/mcl - Hemoglobin more than 10mg/dL - Platelets more than 100,000/mcl Exclusion Criteria: - Patients who had received previous chemotherapy for MPM - Patients who do not accept the treatment |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | National Institute of Cancerología | Mexico city | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | 12 months | Yes | |
Primary | Over-all survival | 12 months | Yes |
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