Clinical Trial: VELCADE in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Multicenter, Open-Label, Phase 2 Study of VELCADE (Bortezomib) for Injection in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma and Adeno
Brief Summary: This study will evaluate the safety and efficacy of VELCADE in patients with previously treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features.
Detailed Summary: Bronchioloalveolar carcinoma (BAC) and adenocarcinoma with bronchioloalveolar features are distinct subtypes of non-small-cell lung cancer which are difficult to treat in advanced stages. This study will determine the safety and efficacy of VELCADE therapy in patients with advanced BAC or adenocarcinoma with BAC features who have failed epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy.
Sponsor: Millennium Pharmaceuticals, Inc.
Current Primary Outcome:
Original Primary Outcome: Objective tumor response rate (complete response [CR] and partial response [PR]) in patients with locally advanced (stage IIIB) or metastatic (stage IV) BAC or adenocarcinoma with BAC features
Current Secondary Outcome:
Original Secondary Outcome:
- Establish time to progression (TTP)
- Determine response rates in patients who have not received prior treatment with an EGFR inhibitor
- Determine disease stabilization rate (CR, PR and stable disease [SD])
- Determine overall survival and progression-free survival (PFS)
Information By: Millennium Pharmaceuticals, Inc.
Dates:
Date Received: June 30, 2005
Date Started: April 2005
Date Completion:
Last Updated: February 16, 2011
Last Verified: February 2011
