Loading clinical trials...
Loading clinical trials...
A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in Previously Untreated Patients With Measurable Disease With Cancer of Unknown Primary (CUP)
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.
OBJECTIVES: Primary * Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus. Secondary * Assess time to progression, overall survival, duration of response, and time to treatment failure in patients treated with this regimen. * Determine adverse events of this regimen in these patients. * Perform descriptive correlative studies to determine response of specific tumor types, identified by the Origin-FFPE test, to this regimen. OUTLINE: This is a multicenter study. Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive oral everolimus once daily on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients' tumor tissue samples from the most recent biopsy are analyzed for correlative studies, including gene expression profiling by Origin-FFPE test. After completion of study therapy, patients are followed up every 3 months until disease progression, and then every 6 months for up to 3 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States
Moline, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
St. Francis Hospital Cancer Care Services
Indianapolis, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Start Date
September 1, 2009
Primary Completion Date
December 1, 2012
Completion Date
August 1, 2013
Last Updated
March 21, 2017
46
ACTUAL participants
carboplatin
DRUG
everolimus
DRUG
paclitaxel
DRUG
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions