Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00081107|
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : June 5, 2013
RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: epothilone D||Phase 2|
- Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy.
- Determine the safety of this drug in these patients.
- Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug.
- Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment.
- Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.
OUTLINE: This is a multicenter, open-label study.
Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081107
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Naiyer Rizvi, MD||Memorial Sloan Kettering Cancer Center|