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)
Overview
- Phase
- Phase 2
- Intervention
- carboplatin
- Conditions
- Carcinoma of Unknown Primary Origin
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 46
- Locations
- 139
- Primary Endpoint
- Percentage of Participants With Confirmed Tumor Responses
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: carboplatin
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.
Intervention: everolimus
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.
Intervention: paclitaxel
Outcomes
Primary Outcomes
Percentage of Participants With Confirmed Tumor Responses
Time Frame: First 6 Cycles of treatment (an average of 6 months)
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;
Secondary Outcomes
- Time to Treatment Failure(Up to 3 years)
- Overall Survival(Time from registration to death or last follow-up (up to 3 years))
- Progression-free Survival(Time from registration to the disease progression or death (up to 3 years))
- Duration of Response(Up to 3 years)