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BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Registration Number
NCT00054314
Lead Sponsor
Roswell Park Cancer Institute
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer.

Detailed Description

OBJECTIVES:

* Determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862.

* Determine the overall survival of patients treated with this drug.

* Determine duration of response and time to progression in patients treated with this drug.

* Determine the quantitative and qualitative toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2-4 additional courses beyond maximal response.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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