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

Phase 2

• Conditions: Melanoma
• Interventions: Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab

• Registration Number: NCT02023710
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-24
• Study First Posted: 2013-12-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BEV plus Chemotherapy	Bevacizumab	Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
BEV plus Chemotherapy	Paclitaxel	Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
Chemotherapy alone	Carboplatin	Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
BEV plus Chemotherapy	Carboplatin	Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
Chemotherapy alone	Paclitaxel	Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Yunan Tumor Hospital; 🇨🇳 Kunming, China