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

Phase 2UnknownNCT02023710

Peking University Cancer Hospital & Institute182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

182

Conditions

Melanoma

Interventions

PaclitaxelDRUG

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)

CarboplatinDRUG

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

BevacizumabDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

Yunan Tumor Hospital

Kunming, China

RECRUITING

Outcomes

Primary Outcomes

progress-free survival(PFS)

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

Time frame: From randomization up to 144 weeks

Secondary Outcomes

adverse event(AE)

Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial

Time frame: From randomization up to144 weeks

Overall Survival(OS)

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

Time frame: Up to 144 weeks

Central Contacts

Xinan Sheng, MD

CONTACT

0086-10-88196951 doctor_sheng@126.com

Data from ClinicalTrials.gov

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