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

NCT00331409 | Completed Phase 2 Results DMC

• 5 other identifiers: IRB00001754OHSU-SOL-05108-LMFWA00000161OHSU-1754CDR0000479150
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer; clear cell renal cell carcinoma; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival at 3 Months

  3 months post 1st dose

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

  Up to 4 years

Secondary Outcomes (3)

• Median Time to Progression

  Time to progression

• Number of Subjects That Demonstrated a Reduction in Tumor Measurements.

  Up to 4 years

• Number of Participants With Adverse Events

  Duration of study, Up to 4 years

Study Arms (1)

Everolimus and Imatinib Mesylate

EXPERIMENTAL

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

Drug: Everolimus; Drug: imatinib mesylate

Interventions

Everolimus DRUG

2.5 mg by mouth daily

Also known as: Afinitor, RAD001, Certican

Everolimus and Imatinib Mesylate

imatinib mesylate DRUG

600 mg by mouth daily

Also known as: Gleevec, STI-571

Everolimus and Imatinib Mesylate

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Everolimus; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Our phase II study closed after the first stage of accrual due to an insufficient number of participants who remained progression-free at 3 months, per the study design.

Results Point of Contact

• Title: Christopher W. Ryan
• Organization: Oregon Health and Science University

ryanc@ohsu.edu

503-494-1951

Study Officials

• Christopher W. Ryan, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 26, 2017
• Results First Posted: October 5, 2011

Record last verified: 2017-09

Locations

US (1)