A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833

Completed · Phase 1

Conditions studied: Breast Cancer, Cancer, Carcinoma, Renal Cell, Lymphoma, Ovarian Cancer

In brief

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.

Key facts

Study ID
NCT00001383
Run by
National Cancer Institute (NCI)
People needed
52
Starts
1994-03-01
Expected to finish
2001-01-01
Last updated by the study team
2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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