R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005989|
Recruitment Status : Completed
First Posted : April 20, 2004
Last Update Posted : August 4, 2011
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 R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: tipifarnib||Phase 2|
- Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib.
- Determine the clinical toxicities of this treatment in these patients.
- Assess the overall survival and time to progression of this patient population when treated with this regimen.
- Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib.
- Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity, pharmacokinetics, and response to this treatment in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
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): NCT00005989
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Julian Molina, MD||Mayo Clinic|
|Principal Investigator:||Elizabeth Johnson, MD||Mayo Clinic|