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Metastatic MelanomaPhase 2NCT00591734

RAD001 Plus Bevacizumab in Metastatic Melanoma

A Phase 2 study testing Bevacizumab and Everolimus in people with Metastatic Melanoma, run by SCRI Development Innovations, LLC at 15 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 is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Bevacizumab and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
15 sitesUnited States
Study dates
Jan 2008to Oct 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 confirmed melanoma.
  • Unresectable stage IV disease, or recurrent disease with metastases.
  • Measurable disease (by Response Evaluation Criteria in Solid Tumors [RECIST]) or measurable skin lesions.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
  • Life expectancy >=12 weeks.
  • Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
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  • Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
  • Absolute neutrophil count (ANC) >=1500/µL, and platelets >=100,000/µL.
  • Serum creatinine <=2.0 mg/dL.
  • Serum bilirubin <=1.5 mg/dL institutional upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × ULN or <5 × ULN in patients with documented liver metastases.

Who cannot join

  • Previous treatment with bevacizumab or other anti-angiogenesis agents.
  • Previous treatment with mTOR inhibitors.
  • Drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A are not allowed.
  • Treatment with investigational agents within 4 weeks of study entry.
  • Treatment with more than two previous chemotherapy regimens.
  • Immunization with attenuated live vaccines within one week of study or anytime during study treatment period.
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  • Female patients who are pregnant or breastfeeding.
  • Central nervous system (CNS) involvement by metastatic melanoma.
  • CNS disease (e.g., seizures not controlled with standard medical therapy, history of stroke).
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
  • Severely impaired lung function.
  • Uncontrolled diabetes as defined by fasting serum glucose >1.5 ULN,
  • Any acute or chronic uncontrolled infection/disorder.
  • Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
  • Any acute or chronic uncontrolled infection/disorder.
  • Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
  • Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • Acute myocardial infarction (MI) with the previous 6 months.
  • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, New York Heart Association [NYHA] Class II or greater congestive heart failure [CHF], serious cardiac arrhythmia requiring medication), or >= grade 2 vascular disease.
  • Clinical history of hemoptysis or hematemesis.
  • Clinical evidence or history of a bleeding diathesis or coagulopathy.
  • Major surgical procedures, fine-needle aspirations, or core biopsies with 7 days of starting treatment.
  • Patients with PEG tubes or G-tubes.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Proteinuria at screening as demonstrated by either
  • Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR
  • Urine dipstick for proteinuria >= 2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible).

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Chattanooga Oncology & Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Consultants in Medical Oncology and Hematology

    Drexel Hill, Pennsylvania, 19026

  • Oncology Hematology Associates of SW Indiana

    Evansville, Indiana, 47714

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

  • South Texas Oncology and Hematology

    San Antonio, Texas, 78258

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida, 33705

Other trials in United States

About this study

Official title: A Phase II Trial of RAD001 Plus Bevacizumab in the Treatment of Patients With Metastatic Melanoma

This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.

Read the detailed description

All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression.

During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.

Fifty-five patients will be enrolled in this multi-centered study

Being tested
Bevacizumab, Everolimus
Keywords
Metastatic Melanoma, Everolimus, RAD001, Bevacizumab
Medical subject headings
Melanoma

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.

  • EverolimusDrug

    Also called Afinitor, RAD001

    10 mg by mouth daily

Study groups in NCT00591734
Study groupRoleWhat they receive
InterventionExperimentalAll patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
Receives: Drug: Bevacizumab; Drug: Everolimus

What is being measured

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

  1. Progression-free Survival

    Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease

    Measured: 13 months

Secondary outcomes (2)

  1. Overall Survival Rate

    Overall Survival is defined as the length of time, in months, that patients were alive from their first date of protocol treatment until death. For patients who were alive at the time of calculation, follow-up time was censored at date of last contact. The percentage of patients who were alive at 1 year is reported here. This was estimated using the Kaplan Meier method.

    Measured: 1 year

  2. Objective Response Rate (ORR)

    The percentage of patients who experience an objective benefit from treatment (CR+PR). The response categories were assigned using RECIST criteria. Complete Response (CR) = Disappearance of all target lesions ; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: 13 months

Timeline

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

  1. First posted11 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2010
  4. Study completionOct 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
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00591734
Sponsor's protocol ID
SCRI MEL 16
Status last verified
Nov 2021
First submitted
26 Dec 2007
Last updated
24 Nov 2021
Data monitoring committee
No

Publications

  • Hainsworth JD, Infante JR, Spigel DR, Peyton JD, Thompson DS, Lane CM, Clark BL, Rubin MS, Trent DF, Burris HA 3rd. Bevacizumab and everolimus in the treatment of patients with metastatic melanoma: a phase 2 trial of the Sarah Cannon Oncology Research Consortium. Cancer. 2010 Sep 1;116(17):4122-9. doi: 10.1002/cncr.25320.

    PubMed 20564157

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Everolimus in people with Metastatic Melanoma, run by SCRI Development Innovations, LLC at 15 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 10 inclusion and 27 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 26 Feb 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 (time frame: 13 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 NCT00591734, 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 24 Nov 2021.

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