A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
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|ClinicalTrials.gov Identifier: NCT00001383|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses.
Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cancer Carcinoma, Renal Cell Lymphoma Ovarian Cancer||Drug: PSC 833 Drug: paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Official Title:||A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833|
|Study Start Date :||March 1994|
|Estimated Study Completion Date :||January 2001|
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): NCT00001383
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|