Status:
COMPLETED
Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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 everoli...
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 \[CR\], pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00331409
Start Date
January 1 2006
End Date
January 1 2010
Last Update
October 26 2017
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098