Phase I trial of a combination of R115777 in combination w/Paclitaxel and Carboplatin in patients w/advanced cancer. Paclitaxel and carboplatin is an active regimen against a number of malignancies, including lung cancer and therefore this regimen is being developed w/the intention of pursuing future phase II and phase III studies. R115777 is a new oral agent that inhibits signal trasduction by blocking farnesylation of the ras protein. Interestingly, R115777 appears to be more active against normal ras than mutated ras, but has been active against all three types of ras proteins. SPECIFIC ENDPOINTS: (1)To determine dose limiting toxicity (DLT) and MTD of chronic oral, q12 hours administration of R115777 in combination w/paclitaxel/carboplatin. (2))To investigate potential pharmacokinetic interactions. (3)To evaluate performance of the FACT-G quality of life instrument in subjects w/advanced cancer. (4)To determine whether an increase in unfarnesylated lamin B1 can be detected in circulating cells obtained from subjects receiving R115777 orally and carboplatin/paclitaxel intravenouly.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-41
Application #
6423999
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
41
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Type
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37203
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