Trials / Completed
CompletedNCT00054314
BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer
An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ortataxel |
Timeline
- Start date
- 2002-03-01
- Primary completion
- 2003-04-01
- First posted
- 2003-02-06
- Last updated
- 2022-09-26
Source: ClinicalTrials.gov record NCT00054314. Inclusion in this directory is not an endorsement.