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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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
Unnamed facility
Moline, Illinois, United States
Percentage of Participants With Confirmed Tumor Responses
Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Time frame: First 6 Cycles of treatment (an average of 6 months)
Overall Survival
Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.
Time frame: Time from registration to death or last follow-up (up to 3 years)
Progression-free Survival
The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.
Time frame: Time from registration to the disease progression or death (up to 3 years)
Duration of Response
Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.
Time frame: Up to 3 years
Time to Treatment Failure
Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.
Time frame: Up to 3 years
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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
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