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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

The clinical study entitled "A Phase I Study of Infusional Paclitaxel with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for the proposed P-glycoprotein antagonist, PSC 833, in combination with paclitaxel. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study ...

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ALL

Eligibility criteria

• • 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.