Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
|ClinicalTrials.gov Identifier: NCT00936702|
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : February 16, 2017
Last Update Posted : March 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of Unknown Primary Origin||Drug: carboplatin Drug: everolimus Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||September 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||August 2013|
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
- 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;
- Overall Survival [ Time Frame: Time from registration to death or last follow-up (up to 3 years) ]Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.
- Progression-free Survival [ Time Frame: Time from registration to the disease progression or death (up to 3 years) ]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.
- Duration of Response [ Time Frame: Up to 3 years ]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 to Treatment Failure [ Time Frame: Up to 3 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936702
Show 141 Study Locations
|Study Chair:||Matthew P. Goetz, MD||Mayo Clinic|