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

NCT00886028 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2009-04-22

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

DRUG

Liposomal doxorubicin

Liposomal doxorubicin 60 mg/m2 every 4 weeks for 6 cycles. Thirty patients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM from the Instituto Nacional de Cancerología and the Instituto Nacional de Enfermedades Respiratorias were included to receive LD 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles.

DRUG

Cisplatin

Cisplatin 80 mg/m2 every 4 weeks for 6 cycles. Thirty patients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM from the Instituto Nacional de Cancerología and the Instituto Nacional de Enfermedades Respiratorias were included to receive LD 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles.

Sponsors & Collaborators

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Enrique Estrada Lobato, M.D. · National Institute of Cancerología

  • Luis Alberto Medina Velázquez, PhD. · Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM

  • Elena Arechaga Ocampo, PhD. · National Institute of Cancerología

  • Victoria López Rodrígez, Q.F.B. · National Institute of Cancerología

  • Luisa Geraldine Villanueva Rodríguez, M.D · National Institute of Canerología

  • Miguel Angel Ríos Trejo, M.D. · National Institute of Cancerología

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-04-30
Completion
2009-06-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00886028 on ClinicalTrials.gov