Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)
|ClinicalTrials.gov Identifier: NCT01122615|
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : November 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Cancer Kidney Cancer||Drug: Sunitinib Drug: Temsirolimus||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Sunitinib + Temsirolimus
Sunitinib 12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle. Temsirolimus 6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle.
Other Names:Drug: Temsirolimus
6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
- Maximum Tolerated Dose (MTD) of Sunitinib and Temsirolimus [ Time Frame: 21 days ]Determination of MTD based on the occurrence of dose limiting toxicities (DLTs) during cycle one only after administration of study drugs on day one through day 21. All toxicity graded according to criteria of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.0.
- Response Rate [ Time Frame: 6 weeks ]Response and progression evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the index tumor lesions are used in the RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LDof target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122615
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Nizar M. Tannir, MD||UT MD Anderson Cancer Center|