Clinical Trials /

Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma

NCT02023710

Description:

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.

Related Conditions:
  • Mucosal Melanoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma
  • Official Title: A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma

Clinical Trial IDs

  • ORG STUDY ID: BCH-MM-131101
  • NCT ID: NCT02023710

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
PaclitaxelTaxelBEV plus Chemotherapy
CarboplatinCBPBEV plus Chemotherapy
BevacizumabBEVBEV plus Chemotherapy

Purpose

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.

Detailed Description

      Mucosal melanoma is rare and associated with extremely poor prognosis.It is the second most
      common subtype in Asians.No effective treatment for advanced mucosal melanoma
      patients.Malignant melanoma is a highly vascular tumor in which vascular endothelial growth
      factor(VEGF) is strongly expressed and seems to play an important role in disease
      progression.A randomized phase II study evaluated the activity of Bevacizumab in combination
      with carboplatin plus paclitaxel(CPB arm) in patients with previously untreated advanced
      melanoma.Overall response rates was 25.5%,median overall survival time(OS) was 12.3 months in
      the CPB arm. 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 Arms

NameTypeDescriptionInterventions
BEV plus ChemotherapyExperimentalPaclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
  • Paclitaxel
  • Carboplatin
  • Bevacizumab
Chemotherapy aloneActive ComparatorPaclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
  • Paclitaxel
  • Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed mucosal melanoma with metastases and has no received any
             systemic treatment.

          2. ECOG performance status 0, 1

          3. Estimated life expectancy of 12 weeks or greater

          4. Age 18 years or older, male or female

          5. At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).

          6. Adequate organ function

          7. Without symptoms of brain metastases and stable in neuro-functions.

          8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures

        Exclusion Criteria:

          1. Mutations in C-KIT or BRAF-V600E, asked for other target treatments

          2. Pregnant or lactation women

          3. Acute infections without control.

          4. Heart disease history, cardiac function class≥NYHA II.

          5. HIV positive or chronic HBV/HCV in active stage.

          6. Brain metastases or primary tumor with positive symptoms

          7. Need anti-epileptic treatments

          8. Organ transplantation history

          9. Hemorrhagic tendency or related history

         10. Renal dialysis patients

         11. Diagnosis of any second malignancy within the last 3 years, except for adequately
             treated.

         12. Current treatment on another clinical trial

         13. The other improper situations which investigator judged.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:progress-free survival(PFS)
Time Frame:From randomization up to 144 weeks
Safety Issue:
Description:Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.

Secondary Outcome Measures

Measure:adverse event(AE)
Time Frame:From randomization up to144 weeks
Safety Issue:
Description:Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial
Measure:Overall Survival(OS)
Time Frame:Up to 144 weeks
Safety Issue:
Description:Overall survival was defined as the time from randomization to death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Beijing Cancer Hospital

Trial Keywords

  • mucosal melanoma
  • Bevacizumab
  • Carboplatin
  • Paclitaxel

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