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

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.

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.

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.