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Report for Clinical Trial NCT02023710

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma

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.

NCT02023710 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: Paclitaxel

Description: 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)
Type: Drug
Group Labels: 2

BEV plus Chemotherapy Chemotherapy alone

Name: Carboplatin

Description: Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 4-week cycle
Type: Drug
Group Labels: 2

BEV plus Chemotherapy Chemotherapy alone

Name: Bevacizumab

Description: 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)
Type: Drug
Group Labels: 1

BEV plus Chemotherapy


Primary Outcomes

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

Measure: progress-free survival(PFS)

Time: From randomization up to 144 weeks

Secondary Outcomes

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: adverse event(AE)

Time: From randomization up to144 weeks

Description: Overall survival was defined as the time from randomization to death from any cause.

Measure: Overall Survival(OS)

Time: Up to 144 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---



HPO Nodes


HPO: