Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00331409|
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : October 5, 2011
Last Update Posted : October 26, 2017
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: Everolimus Drug: imatinib mesylate||Phase 2|
- Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response [CR], partial response [PR], or stable disease [SD]) at 3 months after treatment with everolimus and imatinib mesylate.
- Estimate median time to progression in patients treated with this regimen.
- Determine the proportion of patients whose best overall response are CR, PR, SD, or progressive disease.
- Evaluate the mean and range of the maximum percent reduction in tumor size.
- Describe the toxicities of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: Everolimus and Imatinib Mesylate
Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
2.5 mg by mouth daily
Drug: imatinib mesylate
600 mg by mouth daily
- Progression-free Survival at 3 Months [ Time Frame: 3 months post 1st dose ]
- Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months [ Time Frame: Up to 4 years ]
- Median Time to Progression [ Time Frame: Time to progression ]
- Number of Subjects That Demonstrated a Reduction in Tumor Measurements. [ Time Frame: Up to 4 years ]Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Number of Participants With Adverse Events [ Time Frame: Duration of study, Up to 4 years ]
Toxicity assessments will be obtained as follows:
Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles
Safety assessments will consist of evaluating adverse events and serious adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331409
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Christopher W. Ryan, MD||OHSU Knight Cancer Institute|