Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Cancer
• Interventions: Drug: Everolimus; Drug: imatinib mesylate

• Registration Number: NCT00331409
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-06-13
• Results First Submitted QC: 2011-09-06
• Results First Posted: 2011-10-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus and Imatinib Mesylate	imatinib mesylate	Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Everolimus and Imatinib Mesylate	Everolimus	Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth

Primary Outcome Measures

Name	Time	Method
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months	Up to 4 years
Progression-free Survival at 3 Months	3 months post 1st dose

Secondary Outcome Measures

Name	Time	Method
Number of Subjects That Demonstrated a Reduction in Tumor Measurements.	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	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.
Median Time to Progression	Time to progression

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States