Clinical trial NCT02023710: Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma
Official title: A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Keywords: mucosal melanoma
Bevacizumab
Carboplatin
Paclitaxel
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: progress-free survival(PFS)
timeFrame: From randomization up to 144 weeks
Secondary outcomes:
measure: adverse event(AE)
timeFrame: From randomization up to144 weeks
measure: Overall Survival(OS)
timeFrame: Up to 144 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Kunming
country: China
facility: Yunan Tumor Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KB, Sosman JA, Fruehauf JP, Linette GP, Markovic SN, McDermott DF, Weber JS, Nguyen H, Cheverton P, Chen D, Peterson AC, Carson WE 3rd, O'Day SJ. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. J Clin Oncol. 2012 Jan 1;30(1):34-41. doi: 10.1200/JCO.2011.34.6270. Epub 2011 Nov 28.
citation: Chi Z, Li S, Sheng X, Si L, Cui C, Han M, Guo J. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases. BMC Cancer. 2011 Feb 25;11:85. doi: 10.1186/1471-2407-11-85.
citation: Lian B, Si L, Cui C, Chi Z, Sheng X, Mao L, Li S, Kong Y, Tang B, Guo J. Phase II randomized trial comparing high-dose IFN-alpha2b with temozolomide plus cisplatin as systemic adjuvant therapy for resected mucosal melanoma. Clin Cancer Res. 2013 Aug 15;19(16):4488-98. doi: 10.1158/1078-0432.CCR-13-0739. Epub 2013 Jul 5.
citation: Yan X, Sheng X, Chi Z, Si L, Cui C, Kong Y, Tang B, Mao L, Wang X, Lian B, Li S, Bai X, Zhou L, Dai J, Yao H, Guo J. Randomized Phase II Study of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma. J Clin Oncol. 2021 Mar 10;39(8):881-889. doi: 10.1200/JCO.20.00902. Epub 2021 Jan 14.