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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Everolimus
imatinib mesylate
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria: Measurable metastatic disease Locally unresectable disease No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 8 g/dL Bilirubin < 1.5 times upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 2.5 times ULN Creatinine < 1.5 times ULN No New York Heat Association grade III-IV cardiac disease No other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant or inactive disease No chronic liver disease (i.e., chronic active hepatitis or cirrhosis) No severe or uncontrolled medical disease No gastrointestinal disease or impairment that would hinder the absorption of everolimus No uncontrolled diabetes No chronic renal disease No active uncontrolled infection No congestive heart failure No myocardial infarction within the past 6 months PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 2 weeks since prior major surgery More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C) More than 4 weeks since prior immunotherapy More than 4 weeks since other prior investigational agents No prior radiotherapy to > 25% of bone marrow No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor No concurrent therapeutic warfarin

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus and Imatinib Mesylate

Arm Description

Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth

Outcomes

Primary Outcome Measures

Progression-free Survival at 3 Months
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2006
Last Updated
September 25, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00331409
Brief Title
Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus and Imatinib Mesylate
Arm Type
Experimental
Arm Description
Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Afinitor, RAD001, Certican
Intervention Description
2.5 mg by mouth daily
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
Gleevec, STI-571
Intervention Description
600 mg by mouth daily
Primary Outcome Measure Information:
Title
Progression-free Survival at 3 Months
Time Frame
3 months post 1st dose
Title
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
Secondary Outcome Measure Information:
Title
Median Time to Progression
Time Frame
Time to progression
Title
Number of Subjects That Demonstrated a Reduction in Tumor Measurements.
Description
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.
Time Frame
Up to 4 years
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
Duration of study, Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria: Measurable metastatic disease Locally unresectable disease No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 8 g/dL Bilirubin < 1.5 times upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 2.5 times ULN Creatinine < 1.5 times ULN No New York Heat Association grade III-IV cardiac disease No other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant or inactive disease No chronic liver disease (i.e., chronic active hepatitis or cirrhosis) No severe or uncontrolled medical disease No gastrointestinal disease or impairment that would hinder the absorption of everolimus No uncontrolled diabetes No chronic renal disease No active uncontrolled infection No congestive heart failure No myocardial infarction within the past 6 months PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 2 weeks since prior major surgery More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C) More than 4 weeks since prior immunotherapy More than 4 weeks since other prior investigational agents No prior radiotherapy to > 25% of bone marrow No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor No concurrent therapeutic warfarin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W. Ryan, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

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

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