Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: RAD001

Drug: bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00323739

SCRI GU 32

Details and patient eligibility

About

This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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