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Kidney CancerPhase 2NCT00323739

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

A Phase 2 study testing bevacizumab and RAD001 in people with Kidney Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
bevacizumab and RAD001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
12 sitesUnited States
Study dates
May 2006to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Gainsville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Wellstar Cancer Research

    Marietta, Georgia, 30060

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Kidney Cancer
Being tested
bevacizumab, RAD001
Keywords
kidney cancer, bevacizumab
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    Also called Avastin

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

  • RAD001Drug

    Also called Everolimus

    RAD001 10 mg by mouth daily

Study groups in NCT00323739
Study groupRoleWhat they receive
Bevacizumab and RAD001ExperimentalBevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily
Receives: Drug: bevacizumab; Drug: RAD001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 months

Secondary outcomes (1)

  1. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionNov 2008
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323739
Sponsor's protocol ID
SCRI GU 32
Status last verified
Jul 2013
First submitted
5 May 2006
Last updated
26 Jul 2013
Data monitoring committee
No

Publications

  • Hainsworth JD, Spigel DR, Burris HA 3rd, Waterhouse D, Clark BL, Whorf R. Phase II trial of bevacizumab and everolimus in patients with advanced renal cell carcinoma. J Clin Oncol. 2010 May 1;28(13):2131-6. doi: 10.1200/JCO.2009.26.3152. Epub 2010 Apr 5.

    PubMed 20368560

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and RAD001 in people with Kidney Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00323739, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.

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