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

OHSU Knight Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: imatinib mesylate

Drug: Everolimus

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00331409

OHSU-SOL-05108-LM (Other Identifier)

CDR0000479150 (Other Identifier)

FWA00000161 (Other Identifier)

IRB00001754

OHSU-1754 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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