Viewing Study NCT00055757



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Study NCT ID: NCT00055757
Status: COMPLETED
Last Update Posted: 2013-06-04
First Post: 2003-03-06

Brief Title: Tipifarnib Gemcitabine and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Phase II Trial of R115777 a Farnesyl Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer NSCLC
Status: COMPLETED
Status Verified Date: 2013-06
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: Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Combining tipifarnib with combination chemotherapy may kill more tumor cells
Detailed Description: PRIMARY OBJECTIVES

I To describe the response rate in non-small cell lung cancer NSCLC patients receiving combination therapy with R115777 gemcitabine and cisplatin

SECONDARY OBJECTIVES

I To estimate the time to event efficacy variables including time to progressive disease time to treatment failure time to death of any cause

II To estimate the duration of response for responding patients III To characterize the toxicities of R115777 gemcitabine and cisplatin in this patient population

TERTIARY OBJECTIVES

I To evaluate the association between polymorphism expression in candidate genes and clinical endpoints and toxicity to R115777 gemcitabine and cisplatin

OUTLINE This is a multicenter study

Patients receive oral tipifarnib twice daily on days 1-14 gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity

Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

Patients are followed every 6 months for 2 years

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
N01CM17102 NIH None httpsreporternihgovquickSearchN01CM17102
MC0123 None None None
N01CM17104 NIH None None