Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma
Recruitment status was: Recruiting
|Mesothelioma||Drug: Velcade (bortezomib) plus Eloxatin (oxaliplatin)||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma|
- Objective tumor response rate [ Time Frame: Every 28 days post cycle treatment ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|