A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Melanoma
- Sponsor
- Peking University Cancer Hospital & Institute
- Enrollment
- 182
- Locations
- 3
- Primary Endpoint
- progress-free survival(PFS)
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
Jun Guo
Director of department of renal cancer and melanoma
Peking University Cancer Hospital & Institute
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
BEV plus Chemotherapy
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
Intervention: Paclitaxel
BEV plus Chemotherapy
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
Intervention: Carboplatin
BEV plus Chemotherapy
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
Intervention: Bevacizumab
Chemotherapy alone
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
Intervention: Paclitaxel
Chemotherapy alone
Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
Intervention: Carboplatin
Outcomes
Primary Outcomes
progress-free survival(PFS)
Time Frame: From randomization up to 144 weeks
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.
Secondary Outcomes
- adverse event(AE)(From randomization up to144 weeks)
- Overall Survival(OS)(Up to 144 weeks)