Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer

Phase 2

Completed

• Conditions: Bronchoalveolar Cell Lung Cancer; Non-small Cell Lung Cancer; Adenocarcinoma of the Lung; Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
• Interventions: Drug: bortezomib

• Registration Number: NCT00118144
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with this drug.

II. Determine the time to disease progression in patients treated with this drug.

III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).

Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for survival.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-07-08
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-04
• Results First Submitted: 2014-08-04
• Results First Submitted QC: 2014-08-04
• Last Update Submitted: 2014-08-04
• Results First Posted: 2014-08-21
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	bortezomib	Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.	Up to 5 years	A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to 5 years	Progression Free Survival using the product-limit method of Kaplan and Meier
Overall Survival	Up to 5 years	Overall Suvival using the product-limit method of Kaplan and Meier.

Trial Locations

Locations (1)

City of Hope; 🇺🇸 Duarte, California, United States