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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT02023710
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 30, 2013
Start date
Dec 31, 2013
Status verified
May 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BEV plus Chemotherapy
    Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
  • Active Comparator: Chemotherapy alone
    Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle

Primary Outcome Measure

progress-free survival(PFS) [ Time Frame: From randomization up to 144 weeks ]

Central Contacts

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