Breast Cancer Clinical Trial
Official title:
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | January 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Biopsy proven advanced cancer, for whom no better therapy exists. Enrollment of patients with breast cancer, lymphoma, renal cell cancer or ovarian cancer are encouraged. Patients with a life expectancy of at least 16 weeks, and a performance status (Karnofsky Scale) of 70% or greater. No rapidly growing disease. Patients with prior therapy. WBC greater than 3,000/mm(3) and AGC greater than 1000/mm(3); platelets greater than 100,000/mm(3). Creatinine clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; SGOT less than 90 u/L; SGPT less than 100 u/L. Patients must sign an informed consent and have geographic accessibility to return for follow up and treatment. No history of brain metastases. No patients currently receiving treatment with the following agents or any other agent known to significantly interact with cyclosporine, and the treatment cannot be discontinued , or changed to another therapeutically equivalent allowable drug: acetazolamide, barbiturates, corticosteroids, diltiazem, erythromycin, fluconazole, ketoconazole, nicardipine, phenothiazines, phenytoin, rifampin, sulfonamides, trimethoprim, verapamil, tamoxifen, progesterone, quinine, quinidine, or amiodarone. No patients with a history of coronary artery disease with angina pectoris or history of congestive heart failure. No patients with a history of cardiac disease, other than angina pectoris or congestive heart failure, including patients with arrhythmias or conduction system abnormalities will be considered on an individual basis. No patients with symptomatic peripheral neuropathy (grade 2 or greater). No patients with a positive serology for HIV. No patients who are pregnant or unwilling to practice adequate contraception. No patients with prior bone marrow transplantation or extensive irradiation resulting in compromised bone marrow reserve. |
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute (NCI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Boote DJ, Dennis IF, Twentyman PR, Osborne RJ, Laburte C, Hensel S, Smyth JF, Brampton MH, Bleehen NM. Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer. J Clin Oncol. 1996 Feb;14(2):610-8. — View Citation
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