NCT00255762

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

October 28, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

November 18, 2005

Last Update Submit

October 25, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

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

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

Secondary Outcomes (3)

  • Confirmed tumor response (complete response or partial response)

    Up to 5 years

  • Clinical response rate

    Up to 5 years

  • Overall survival

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

Study Arms (1)

Treatment (carboplatin, paclitaxel, bevacizumab)

EXPERIMENTAL

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.

Drug: carboplatinDrug: paclitaxelBiological: bevacizumabOther: laboratory biomarker analysis

Interventions

carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (carboplatin, paclitaxel, bevacizumab)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (carboplatin, paclitaxel, bevacizumab)
bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (carboplatin, paclitaxel, bevacizumab)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (carboplatin, paclitaxel, bevacizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +50 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

CarboplatinPaclitaxelTaxesBevacizumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Svetomir Markovic

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2006

Last Updated

October 28, 2013

Record last verified: 2013-10

Locations

US(1)