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Recurrent MelanomaPhase 2NCT00255762

Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

A Phase 2 study testing carboplatin, paclitaxel and bevacizumab in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site 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 is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
carboplatin, paclitaxel and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
Dec 2005to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Evidence of metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No radiologically confirmed invasion of adjacent organs (e.g., duodenum or stomach)
  • No tumor invasion of major blood vessels
Show all 65Show fewer
  • No history of primary brain tumor or other CNS disease
  • No brain metastases by MRI or CT scan
  • Performance status - ECOG 0-2
  • More than 4 months
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusion allowed)
  • No active bleeding
  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • INR ≤ 1.5 times ULN
  • PTT normal
  • No known esophageal varices
  • Creatinine ≤ 1.5 times ULN
  • Urine protein creatinine ratio ≤ 0.5
  • Urine protein < 1 g/24-hr urine collection
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No myocardial infarction within the past 6 months
  • No unstable angina within the past 6 months
  • No clinically significant peripheral vascular disease
  • No uncontrolled hypertension (i.e., blood pressure ≥ 150/90 mmHg despite antihypertensive therapy)
  • No clinically significant stroke within the past 6 months
  • No deep vein thrombosis within the past year
  • No other vascular abnormality
  • No pulmonary embolus within the past year
  • No history of abdominal fistula
  • No gastrointestinal perforation
  • No intra-abdominal abscess within the past 4 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • No other pathological condition that would confer a high risk of bleeding
  • No active infection requiring parenteral antibiotics
  • No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
  • No peripheral neuropathy ≥ grade 2
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs
  • No uncontrolled seizures
  • No other uncontrolled illness
  • No significant traumatic injury within the past 4 weeks
  • No prior antivascular endothelial growth factors (VEGF), including any of the following:
  • Bevacizumab
  • VEGF Trap
  • Anti-VEGF receptor monoclonal antibody
  • Small molecular tyrosine kinase inhibitors of VEGF receptors
  • No more than 1 prior systemic chemotherapy regimen
  • No prior carboplatin or paclitaxel
  • No other concurrent chemotherapy
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No concurrent radiotherapy
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior fine-needle aspiration or core biopsy
  • No concurrent major surgery
  • More than 4 weeks since prior systemic therapy
  • No concurrent full-dose oral or parenteral anticoagulation
  • No concurrent antiplatelet therapy except low-dose aspirin (i.e., 81 mg of oral aspirin daily) allowed
  • No other concurrent experimental drugs

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Trial of Carboplatin, Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma

This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.

Read the detailed description

OBJECTIVES: Primary I. Determine the anti-tumor activity of carboplatin, paclitaxel, and bevacizumab, in terms of progression-free survival, in patients with unresectable stage IV melanoma.

II. Determine the toxicity profile of this regimen in these patients.

Secondary I. Determine the distribution of overall survival times in patients treated with this regimen.

II. Determine the response rate in patients treated with this regimen. III. Determine the changes in blood levels of vascular endothelial growth factor in patients treated with this regimen.

IV. Determine the changes in immune homeostasis in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Being tested
carboplatin, paclitaxel, bevacizumab, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

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

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00255762
Study groupRoleWhat they receive
Treatment (carboplatin, paclitaxel, bevacizumab)ExperimentalPatients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: carboplatin; Drug: paclitaxel; Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

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

  1. Progression free survival

    Constructed using the properties of the binomial distribution. Estimated using the Kaplan-Meier method.

    Measured: Time from registration to documentation of disease progression, assessed up to 8 weeks

Secondary outcomes (3)

  1. Confirmed tumor response (complete response or partial response)

    A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.

    Measured: Up to 5 years

  2. Clinical response rate

    A ninety percent confidence interval for the true clinical response rate will be calculated.

    Measured: Up to 5 years

  3. Overall survival

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Time is defined as the time from registration to death due to any cause, assessed up to 5 years

Timeline

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

  1. First posted21 Nov 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionDec 2006

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255762
Sponsor's protocol ID
NCI-2012-01823
Other IDs
NCI-2012-01823, CDR0000449967, NCCTG-N047A, N047A, U10CA025224
Status last verified
Oct 2013
First submitted
18 Nov 2005
Last updated
28 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, paclitaxel and bevacizumab in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site 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 65 inclusion and 0 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 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: Time from registration to documentation of disease progression, assessed up to 8 weeks). 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 NCT00255762.

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 28 Oct 2013.

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