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Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00331409
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: everolimus
Drug: imatinib mesylate
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Imatinib Imatinib mesylate Everolimus Sirolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 3 months [ Designated as safety issue: No ]
  • Overall response rate (complete response, partial response, and stable disease) at 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time to progression [ Designated as safety issue: No ]
  • Maximum percent reduction of tumor measurement [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: January 2006
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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 subjects will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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)
  • SGOT and 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 mTOR inhibitor
  • No concurrent therapeutic warfarin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331409

Locations
United States, Oregon
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Oregon Health and Science University Cancer Institute
Investigators
Study Chair: Christopher W. Ryan, MD Oregon Health and Science University Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000479150, OHSU-SOL-05108, FWA00000161, OHSU-1754
Study First Received: May 30, 2006
Last Updated: October 25, 2008
ClinicalTrials.gov Identifier: NCT00331409  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma
recurrent renal cell cancer

Study placed in the following topic categories:
Everolimus
Sirolimus
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Imatinib
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Clear cell renal cell carcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009