Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00996385|
Recruitment Status : Unknown
Verified October 2011 by Columbia University.
Recruitment status was: Recruiting
First Posted : October 16, 2009
Last Update Posted : October 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Velcade (bortezomib) plus Eloxatin (oxaliplatin)||Phase 2|
The primary objective of this study is to determine the objective tumor response rate for VELCADE plus ELOXATIN in patients with malignant mesothelioma.
The aims of this study are to: (a)to determine the tumor response rate, median survival, time to response, duration of response and time to treatment failure or progression of disease;(b)to ascertain if in vitro assessment of gene expression profiles via PCR can be used to ascertain a patient's response to VELCADE (bortezomib) therapy (c) to characterize the quantitative and qualitative toxicities of VELCADE plus ELOXATIN in this patient population.
Each cycle of treatment is composed of 28 days and consists of four treatments with VELCADE (d 1,4,15,and 18) and two treatments with ELOXATIN (days 4,and 18). Patients will undergo a physical examination and routine blood work at each visit. A Quality of Life (QOL) assessment will be performed prior to initiating each cycle of therapy and CT scans will be performed at baseline and every 2 cycles (8 weeks)to assess tumor response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2014|
Experimental: Velcade plus Eloxatin
Six 20-day cycles
Drug: Velcade (bortezomib) plus Eloxatin (oxaliplatin)
One cycle is defined as an interval of 28 days. A cycle is comprised of four treatments of Velcade (Bortezomib) 1.3 mg/m2 given on days 1, 14, 15, and 18 and two treatments of Eloxatin (Oxaliplatin) 85 mg/m2 on days 4 and 18.
- Objective tumor response rate [ Time Frame: Every 28 days post cycle treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996385
|Contact: Herbert Irving Comprehensive Cancer Center Clinical Research Management Office||212-305-8615|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator: Robert N Taub, MD, PhD|
|Sub-Investigator: Alain C Borczuk, MD|
|Principal Investigator:||Robert N Taub, MD, PhD||Columbia University|