Melanoma
Conditions
Keywords
mucosal melanoma, Bevacizumab, Carboplatin, Paclitaxel
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.
Interventions
DRUGPaclitaxel
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)
DRUGCarboplatin
Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 4-week cycle
DRUGBevacizumab
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)
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress-free survival(PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| adverse event(AE) | From randomization up to144 weeks | Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial |
| Overall Survival(OS) | Up to 144 weeks | Overall survival was defined as the time from randomization to death from any cause. |
Countries
China
Contacts
Primary ContactXinan Sheng, MD
Outcome results
None listed