NCT00886028

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

Enrollment Period

2.6 years

First QC Date

April 20, 2009

Last Update Submit

April 21, 2009

Conditions

Malignant Pleural Mesothelioma

Keywords

Malignant pleural mesotheliomaLiposomal doxorubicinProgression free survivalPatients who received LD 60mg/m2 plus cisplatin 80 mg/m2 every 4 weeks for 6 cyclesPatients with epithelial, sarcomatoid or biphasic histological confirmed diagnosis of MPM

Outcome Measures

Primary Outcomes (2)

  • Progression free survival

    12 months

  • Over-all survival

    12 months

Study Arms (1)

Liposomal doxorubicin

EXPERIMENTAL

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

Drug: Liposomal doxorubicinDrug: Cisplatin

Interventions

Liposomal doxorubicinDRUG

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.

Liposomal doxorubicin
CisplatinDRUG

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.

Liposomal doxorubicin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who had received previous chemotherapy for MPM
  • Patients who do not accept the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cancerología

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (1)

  • Arrieta O, Medina LA, Estrada-Lobato E, Hernandez-Pedro N, Villanueva-Rodriguez G, Martinez-Barrera L, Macedo EO, Lopez-Rodriguez V, Motola-Kuba D, Corona-Cruz JF. First-line chemotherapy with liposomal doxorubicin plus cisplatin for patients with advanced malignant pleural mesothelioma: phase II trial. Br J Cancer. 2012 Mar 13;106(6):1027-32. doi: 10.1038/bjc.2012.44. Epub 2012 Feb 21.

    PMID: 22353806DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

liposomal doxorubicinCisplatin

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Enrique Estrada Lobato, M.D.

    National Institute of Cancerología

    STUDY CHAIR

  • Luis Alberto Medina Velázquez, PhD.

    Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

September 1, 2006

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

ME(1)