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Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma


All eligible patients will receive:

- Bevacizumab 10mg/kg, IV infusion, every 2 weeks

- RAD001 10 mg by mouth daily

All patients will be evaluated for response after completing two courses (8 weeks) of
treatment. Patients with objective tumor response or stable disease will continue treatment
with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease
progression occurs.


Inclusion Criteria:



- Histologically documented metastatic or unresectable locally recurrent clear cell
renal carcinoma.

- In patients with mixed histologies, the clear cell component must comprise ≥ 75% of
the cancer

- Previous nephrectomy is required with the following exceptions:

- Primary tumor < 5cm

- Extensive liver ( > 30% of liver parenchyma)or

- Multiple (> 5) bone metastases, making nephrectomy a clinically contraindicated
procedure

- Patients may have had a maximum of 1 previous systemic regimen for metastatic disease

- Patients may not have received previous bevacizumab. However, patients who have
received other agents with anti-angiogenic activity (eg. sorafenib, SU11248,
AG-013736, PTK787, thalidomide) as part of first-line treatment are eligible

- Patients may not have received previous treatment with m-TOR inhibitors.

- ECOG performance status 0 or 1

- Measurable disease

- Adequate liver, kidney and bone marrow function

- No previous systemic treatment or radiation therapy for at least 2 weeks prior to
study entry

- Patients must be able to understand the nature of this study and give written
informed consent

Exclusion Criteria:

- Age < 18 years

- Treatment with > 1 previous systemic regimen for metastatic renal carcinoma

- History of acute myocardial infarction within 6 months

- Clinically significant cardiovascular disease

- History of stroke within 6 months

- Patients with active brain metastases

- Patients with meningeal metastases

- Women who are pregnant or lactating

- Patients who have been treated within 5 years for other invasive cancers

- Patients with history or evidence by physical examination of CNS disease

- Patients with clinical history of hemoptysis or hematemesis

- Patients with history of deep vein thrombosis or thromboembolic disease requiring
full dose anticoagulation

- Patients with major surgical procedures, open biopsies, or significant traumatic
injuries within 28 days or anticipated need for major surgical procedure during the
course of the study

- Patients with peg-tubes or G-tubes

- Patients are ineligible if a fine needle aspiration biopsy has been performed within
seven days

- Patients with proteinuria

- Patients with any non-healing wound, ulcer, or long-bone fracture

- Patients with any history of a bleeding diathesis or coagulopathy

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months

- Patients who have received any other experimental drug within 28 days of starting
treatment

- History of any other severe and/or uncontrolled medical disease

- History of HIV infection

- Chronic treatment with steroids or other immunosuppressive agents

- Patients with impaired GI function that compromises the ability to swallow or absorb
RAD001

- Patients who are unwilling or unable to comply with the protocol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI GU 32

NCT ID:

NCT00323739

Start Date:

May 2006

Completion Date:

March 2013

Related Keywords:

  • Kidney Cancer
  • kidney cancer
  • bevacizumab
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Florida Hospital Cancer InstituteOrlando, Florida  32804
Florida Cancer SpecialistsFort Myers, Florida  33901
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Methodist Cancer CenterOmaha, Nebraska  68114
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Wellstar Cancer ResearchMarietta, Georgia  30060
Oncology Hematology CareCincinnati, Ohio  45242
Gainsville Hematology Oncology AssociatesGainesville, Florida  32605
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404