|
A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 Clinical research trials and A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833 condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833  A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
For Condition: Breast Cancer,Cancer,Carcinoma, Renal Cell,Lymphoma,Ovarian Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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 is to define the maximum tolerated dose in combination with paclitaxel, and to determine how the drug affects the pharmacokinetics of paclitaxel. PSC 833 will most likely reduce the clearance of paclitaxel as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of paclitaxel, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. The first cycle of paclitaxel will be given in the absence of PSC 833. Subsequently, 7 days of PSC 833 will be given alone to allow monitoring of pharmacokinetics and adverse effects of PSC 833 alone. In the second cycle, both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 52
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 940119; 94-C-0119
Study Start Date: March 28, 1994
Record last reviewed: March 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001383
Other Cancer Studies:
1. Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment
2. Vinorelbine and XR9576 to Treat Cancer
3. Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
4. Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
5. Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
Related Studies:
Other Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
|
|
|
|
|
|
|
|
