Viewing Study NCT00005872



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005872
Status: COMPLETED
Last Update Posted: 2013-12-04
First Post: 2000-06-02

Brief Title: Nitrocamptothecin in Treating Patients With Recurrent Non-small Cell Lung Cancer
Sponsor: Astex Pharmaceuticals Inc
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase II Study of RFS 2000 in Relapsed NSCLC
Status: COMPLETED
Status Verified Date: 2001-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 nitrocamptothecin in treating patients who have recurrent non-small cell lung cancer
Detailed Description: OBJECTIVES I Determine the response rate time to progression and overall survival of patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin II Assess the toxicities and pharmacokinetics of this regimen in these patients

OUTLINE Patients receive oral nitrocamptothecin daily on days 1-5 Treatment continues weekly in the absence of disease progression or unacceptable toxicity Patients are followed for survival

PROJECTED ACCRUAL A total of 20-55 patients will be accrued for this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DFCI-99184 None None None
SUPERGEN-RFS2000-16 None None None