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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Cancerología.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT00886028
First received: April 20, 2009
Last updated: April 21, 2009
Last verified: April 2009
  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 2

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:


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.


  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by National Institute of Cancerología

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Liposomal doxorubicin
Doxorubicin
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014