NCT02023710

Brief Summary

Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2013

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

December 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

December 19, 2013

Last Update Submit

May 7, 2017

Conditions

Melanoma

Keywords

mucosal melanomaBevacizumabCarboplatinPaclitaxel

Outcome Measures

Primary Outcomes (1)

  • progress-free survival(PFS)

    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.

    From randomization up to 144 weeks

Secondary Outcomes (2)

  • adverse event(AE)

    From randomization up to144 weeks

  • Overall Survival(OS)

    Up to 144 weeks

Study Arms (2)

BEV plus Chemotherapy

EXPERIMENTAL

Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle

Drug: PaclitaxelDrug: CarboplatinDrug: Bevacizumab

Chemotherapy alone

ACTIVE COMPARATOR

Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle

Drug: PaclitaxelDrug: Carboplatin

Interventions

PaclitaxelDRUG

175 mg/m\^2 by IV infusion on the first day of each 4-week cycle (dose was based on patient's weight and could be adjusted for weight change)

Also known as: Taxel
BEV plus ChemotherapyChemotherapy alone
CarboplatinDRUG

Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 4-week cycle

Also known as: CBP
BEV plus ChemotherapyChemotherapy alone
BevacizumabDRUG

5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)

Also known as: BEV
BEV plus Chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment.
  • ECOG performance status 0, 1
  • Estimated life expectancy of 12 weeks or greater
  • Age 18 years or older, male or female
  • At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
  • Adequate organ function
  • Without symptoms of brain metastases and stable in neuro-functions.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if:

  • Mutations in C-KIT or BRAF-V600E, asked for other target treatments
  • Pregnant or lactation women
  • Acute infections without control.
  • Heart disease history, cardiac function class≥NYHA II.
  • HIV positive or chronic HBV/HCV in active stage.
  • Brain metastases or primary tumor with positive symptoms
  • Need anti-epileptic treatments
  • Organ transplantation history
  • Hemorrhagic tendency or related history
  • Renal dialysis patients
  • Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
  • Current treatment on another clinical trial
  • The other improper situations which investigator judged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Yunan Tumor Hospital

Kunming, 650106, China

RECRUITING

Related Publications (4)

  • Kim KB, Sosman JA, Fruehauf JP, Linette GP, Markovic SN, McDermott DF, Weber JS, Nguyen H, Cheverton P, Chen D, Peterson AC, Carson WE 3rd, O'Day SJ. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. J Clin Oncol. 2012 Jan 1;30(1):34-41. doi: 10.1200/JCO.2011.34.6270. Epub 2011 Nov 28.

    PMID: 22124101BACKGROUND

  • Chi Z, Li S, Sheng X, Si L, Cui C, Han M, Guo J. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases. BMC Cancer. 2011 Feb 25;11:85. doi: 10.1186/1471-2407-11-85.

    PMID: 21349197BACKGROUND

  • Lian B, Si L, Cui C, Chi Z, Sheng X, Mao L, Li S, Kong Y, Tang B, Guo J. Phase II randomized trial comparing high-dose IFN-alpha2b with temozolomide plus cisplatin as systemic adjuvant therapy for resected mucosal melanoma. Clin Cancer Res. 2013 Aug 15;19(16):4488-98. doi: 10.1158/1078-0432.CCR-13-0739. Epub 2013 Jul 5.

    PMID: 23833309BACKGROUND

  • Yan X, Sheng X, Chi Z, Si L, Cui C, Kong Y, Tang B, Mao L, Wang X, Lian B, Li S, Bai X, Zhou L, Dai J, Yao H, Guo J. Randomized Phase II Study of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma. J Clin Oncol. 2021 Mar 10;39(8):881-889. doi: 10.1200/JCO.20.00902. Epub 2021 Jan 14.

    PMID: 33444116DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

PaclitaxelCarboplatinBevacizumab

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)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jun Guo, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinan Sheng, MD

CONTACT

0086-10-88196951doctor_sheng@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of renal cancer and melanoma

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 30, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

CN(3)