NCT00001383

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Mar 1994

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1994

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Breast CancerCancerCarcinoma, Renal CellLymphomaOvarian Cancer

Keywords

Cyclosporine AnalogueMultidrug ResistancePgp BlockerPump BlockerTaxol Over 90 Hours

Interventions

PSC 833DRUG
paclitaxelDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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. doi: 10.1200/JCO.1996.14.2.610.

    PMID: 8636778BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsCarcinoma, Renal CellLymphomaOvarian Neoplasms

Interventions

valspodarPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

March 1, 1994

Study Completion

January 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-03

Locations

US(1)