Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma - Full Text View

Sponsor:	National Institute of Cancerología
Information provided by:	National Institute of Cancerología
ClinicalTrials.gov Identifier:	NCT00886028

Purpose

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.

Condition	Intervention	Phase
Malignant Pleural Mesothelioma	Drug: Liposomal doxorubicin Drug: Cisplatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	"Phase II Study: Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma "

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma Palliative Care

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:

Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Over-all survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	31
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Liposomal doxorubicin Thirty patients with MPM who received liposomal doxorubicin 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles.	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.

Arms

Assigned Interventions

Experimental: Liposomal doxorubicin

Thirty patients with MPM who received liposomal doxorubicin 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles.

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886028

Locations

Mexico
National Institute of Cancerología
Mexico city, Distrito Federal, Mexico, 14080

Sponsors and Collaborators

National Institute of Cancerología

Investigators

Study Chair:	Enrique Estrada Lobato, M.D.	National Institute of Cancerología
Study Chair:	Luis Alberto Medina Velázquez, PhD.	UNAM
Study Chair:	Elena Arechaga Ocampo, PhD.	National Institute of Cancerología
Study Chair:	Victoria López Rodrígez, Q.F.B.	National Institute of Cancerología
Study Chair:	Luisa Geraldine Villanueva Rodríguez, M.D	National Institute of Canerología
Study Chair:	Miguel Angel Ríos Trejo, M.D.	National Institute of Cancerología

More Information

No publications provided

Responsible Party:	Oscar Arrieta Rodríguez, CONACYT
ClinicalTrials.gov Identifier:	NCT00886028 History of Changes
Other Study ID Numbers:	CB/304/06, 007/024/OMI
Study First Received:	April 20, 2009
Last Updated:	April 21, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by National Institute of Cancerología:

Malignant pleural mesothelioma
Liposomal doxorubicin
Progression free survival
Patients who received LD 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cycles
Patients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin

Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on February 07, 2012