Conditions: Carcinoma of Unknown Primary Origin
Keywords: Newly Diagnosed Carcinoma of Unknown Primary Origin Squamous Cell Carcinoma of Unknown Primary Origin Undifferentiated Carcinoma of Unknown Primary newly diagnosed carcinoma of unknown primary
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 46
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: carboplatin intervention 2: everolimus intervention 3: paclitaxel
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Given IV

Protocol document: