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MelanomaPhase 2NCT00466687

Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma

A Phase 2 study testing bevacizumab, erlotinib hydrochloride and fluorescence in situ hybridization in people with Melanoma, run by Vanderbilt-Ingram Cancer Center at 4 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

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
bevacizumab, erlotinib hydrochloride and fluorescence in situ hybridization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesUnited States
Study dates
Sep 2004to Sep 2008
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

  • Measurable Stage IV melanoma
  • Easter Cooperative Oncology Group (ECOG) Performance Status must be 0-1
  • Good organ function as demonstrated by, Creatinine <2.mg/dl, AST or ALT <5 times upper limit of normal for subjects with documented liver metastases; <2.5 times the upper limit of normal (ULN) for subjects without evidence of liver metastases, bilirubin<2.0mg/dl,, absolute neutrophil count (ANC)>1500/ul, platelets>75k/ul, hemoglobin (Hgb)>9 (may be transfused to obtain)
  • Prior therapy: adjuvant interferon (IFN) allowed; no more than one prior regimen for advanced stage IV disease
  • Patients must have a life expectancy of >3 months
  • Patients with brain metastases are eligible only if they fulfill the following: resected or stereotactic treatment a minimum of 3 months previously and no active CNS disease since then; brain metastases treated greater than 6 months ago without evidence of progression or hemorrhage, <1cm in size per lesion (up to 3 lesions), and off all steroids
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  • Patients may not have received other agents, either investigational or marketed, which act by either EGFr inhibition or anti-angiogenesis mechanisms. Other epidermal growth factor receptor (EGFR) inhibitors include (but are not limited to): Iressa, erbitux, CI-1033. Angiogenesis inhibitors include (but are not limited to): SU5416, SU6668, SU 0122348, CP547632, VEGF Trap, anti-integrin αVβ3.
  • Recovered from toxicity of major surgery (4 wks), chemotherapy or biologic therapy (4 wks), and/or radiation therapy (2 wks)
  • No active other malignancy within 12 months
  • No active systemic infection
  • Over age of 18 years and signed IRB approved informed consent

Who cannot join

  • Subjects meeting any of the following criteria (3.2.2-3.2.16) are ineligible for study entry
  • Compromised renal or hepatic function as defined by Creatinine >2.0mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) >5 times upper limit of normal for subjects with documented liver metastases; >2.5 times the upper limit of normal (ULN) for subjects without evidence of liver metastases
  • Patient may not be part of any other investigational studies
  • internationalized normal ratio (INR) > 1.5
  • Patients with PEG or G-tube are ineligible.
  • Major surgical procedure, open biopsy; or significant traumatic injury within 28 days, or anticipation of need for major surgical procedure during the course of the study
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  • Any non-healing wound, ulcer, or bone fracture.
  • Any clinical evidence or history of a bleeding diathesis or coagulopathy.
  • Patients with a history of deep vein thrombosis or thromboembolic disease within the past 6 months.
  • History of acute myocardial infarction within 6 months. In addition, patients are ineligible if they have clinically significant cardiovascular disease ((e.g., uncontrolled hypertension [blood pressure of >160/110 mmHg on medication], New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)
  • Patients with > 1+ proteinuria will have 24-hour urine collection; for protein. Patients with ≥ 1gm protein/24 hrs will be excluded
  • If child bearing age must not be pregnant or nursing and use methods to prevent pregnancy
  • History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or history of stroke)
  • Inability to comply with study and/or follow-up procedures
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Vanderbilt-Ingram Cancer Center - Cool Springs

    Nashville, Tennessee, 37067-1631

  • Vanderbilt-Ingram Cancer Center at Franklin

    Nashville, Tennessee, 37067

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

Official title: A Phase II Trial of Tarceva (Erlotinib) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Melanoma

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IV melanoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the overall response rate, response duration, and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydrochloride and bevacizumab.
  • Determine objective responses in patients treated with this regimen.

Secondary

  • Determine the overall safety and tolerability of this regimen in these patients.
  • Evaluate tissue blocks for EGFR by monoclonal antibody H11 (DAKO) or fluorescence in situ hybridization(FISH)7p12-specific probe-overexpression or amplification in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 (DAKO) or fluorescence in situ hybridization (FISH) 7p12-specific probe-overexpression or amplification. Biological markers AKT, MAPK, p27, p21, CD13, CD34, and factor VIII are also measured.

After completion of study treatment, patients are followed periodically.

Conditions
Melanoma
Being tested
bevacizumab, erlotinib hydrochloride, fluorescence in situ hybridization, gene expression analysis, immunologic technique
Keywords
stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

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

  • bevacizumabBiological

    Also called Avastin

    10mg/kg, slow IV infusion, Days 1 and 14

  • erlotinib hydrochlorideDrug

    Also called Tarceva

    150mg PO qd

  • fluorescence in situ hybridizationGenetic

    Targeting multiple genetic aberrations in isolated tumor cells.

  • gene expression analysisGenetic

    gene expression analysis

  • immunologic techniqueOther

    immunologic technique

  • laboratory biomarker analysisOther

    laboratory biomarker analysis

  • biopsyProcedure or surgery

    biopsy

Study groups in NCT00466687
Study groupRoleWhat they receive
Therapeutic InterventionExperimentalTarceva and Avastin: * Tarceva: 150mg PO, days 1-28 * Avastin: 10mg/kg, IV infusion, days 1,15 Regimen will be repeated every 28 days = 1 course
Receives: Biological: bevacizumab; Drug: erlotinib hydrochloride; Genetic: fluorescence in situ hybridization; Genetic: gene expression analysis; Other: immunologic technique; Other: laboratory biomarker analysis; Procedure: biopsy

What is being measured

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

  1. Number of Patients With Response

    Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

    Measured: At 6 months

Secondary outcomes (3)

  1. Time to Disease Progression.

    Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions.

    Measured: up to one year after off-study date

  2. Progression-free Survival at 6 Months

    Patients with Progression-free survival at 6 months

    Measured: 6 months

  3. Number of Patients With Each Worst-grade Toxicity Response

    Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.

    Measured: Day 1 of each 28-day cycle for 6 cycles (168 days)

Timeline

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

  1. First posted27 Apr 2007 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2008
  4. Study completionSep 2008

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00466687
Sponsor's protocol ID
VICC MEL 0418
Other IDs
VU-VICC-MEL-0418, VU-IRB-040468
Status last verified
Jul 2013
First submitted
25 Apr 2007
Last updated
22 Jul 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, erlotinib hydrochloride and fluorescence in situ hybridization in people with Melanoma, run by Vanderbilt-Ingram Cancer Center at 4 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 11 inclusion and 15 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 22 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 4 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 28 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?

Number of Patients With Response (time frame: At 6 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 NCT00466687.

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 22 Jul 2013.

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