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

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331409
• Other study ID #: IRB00001754
• Secondary ID: OHSU-SOL-05108-L
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: September 25, 2017
• Start date: January 2006
• Est. completion date: January 2010

Study information

• Verified date: September 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• Everolimus
2.5 mg by mouth daily
• imatinib mesylate
600 mg by mouth daily

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival at 3 Months		3 months post 1st dose
Primary	Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months		Up to 4 years
Secondary	Median Time to Progression		Time to progression
Secondary	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.	Up to 4 years
Secondary	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.	Duration of study, Up to 4 years