Carcinoma of Unknown Primary Origin Clinical Trial
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)
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment