NCT00996385

Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma

A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to disease progression or completion of therapy, patient's will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.

Detailed description

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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-09-01
• Completion: 2014-09-01
• First posted: 2009-10-16
• Last updated: 2011-10-31

Locations

1 site across 1 country: United States