Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer.
D J Boote, I F Dennis, P R Twentyman...
https://pubmed.ncbi.nlm.nih.gov/8636778Completed
Phase 1
All Genders
ID00001383
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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