Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
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.
Carcinoma of Unknown Primary Origin
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Proportion of confirmed tumor responses defined to be either a CR or PR [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Survival time [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: FroUp to 3 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||August 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (carboplatin, paclitaxel, and everolimus)
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given IVDrug: everolimus
Given PODrug: paclitaxel
- Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936702
Show 141 Study Locations
|Study Chair:||Matthew P. Goetz, MD||Mayo Clinic|