Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: National Institute of Cancerología
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin

Criteria

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