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

Primary Purpose

Melanoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel

Carboplatin

Bevacizumab

About this trial

This is an interventional treatment trial for Melanoma focused on measuring mucosal melanoma, Bevacizumab, Carboplatin, Paclitaxel

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment.
ECOG performance status 0, 1
Estimated life expectancy of 12 weeks or greater
Age 18 years or older, male or female
At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
Adequate organ function
Without symptoms of brain metastases and stable in neuro-functions.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

Mutations in C-KIT or BRAF-V600E, asked for other target treatments
Pregnant or lactation women
Acute infections without control.
Heart disease history, cardiac function class≥NYHA II.
HIV positive or chronic HBV/HCV in active stage.
Brain metastases or primary tumor with positive symptoms
Need anti-epileptic treatments
Organ transplantation history
Hemorrhagic tendency or related history
Renal dialysis patients
Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
Current treatment on another clinical trial
The other improper situations which investigator judged.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting
Beijing Cancer HospitalRecruiting
Yunan Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BEV plus Chemotherapy

Chemotherapy alone

Arm Description

Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle

Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Overall Survival(OS)

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

Full Information

NCT ID

NCT02023710

First Posted

December 19, 2013

Last Updated

May 7, 2017

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT02023710

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

mucosal melanoma, Bevacizumab, Carboplatin, Paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BEV plus Chemotherapy

Arm Type

Experimental

Arm Description

Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle

Arm Title

Chemotherapy alone

Arm Type

Active Comparator

Arm Description

Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxel

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

CBP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

BEV

Intervention Description

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)

Primary Outcome Measure Information:

Title

progress-free survival(PFS)

Description

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 Outcome Measure Information:

Title

adverse event(AE)

Description

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

Title

Overall Survival(OS)

Description

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

Time Frame

Up to 144 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment. ECOG performance status 0, 1 Estimated life expectancy of 12 weeks or greater Age 18 years or older, male or female At least one measurable site (diameter≥1cm) of disease (RECIST 1.1). Adequate organ function Without symptoms of brain metastases and stable in neuro-functions. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: Mutations in C-KIT or BRAF-V600E, asked for other target treatments Pregnant or lactation women Acute infections without control. Heart disease history, cardiac function class≥NYHA II. HIV positive or chronic HBV/HCV in active stage. Brain metastases or primary tumor with positive symptoms Need anti-epileptic treatments Organ transplantation history Hemorrhagic tendency or related history Renal dialysis patients Diagnosis of any second malignancy within the last 3 years, except for adequately treated. Current treatment on another clinical trial The other improper situations which investigator judged.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinan Sheng, MD

Phone

0086-10-88196951

doctor_sheng@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoshi Zhang, MD

Phone

0086-20-87343088

zxs617@hotmail.com

First Name & Middle Initial & Last Name & Degree

Xiaoshi Zhang, MD

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinan Sheng, MD

Phone

0086-10-88196951

doctor_sheng@126.com

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD

Facility Name

Yunan Tumor Hospital

City

Kunming

ZIP/Postal Code

650106

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Song, MD

Phone

0086-871-8185656

songxin68@126.com

First Name & Middle Initial & Last Name & Degree

Xin Song, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

22124101

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.

Results Reference

background

PubMed Identifier

21349197

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.

Results Reference

background

PubMed Identifier

23833309

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.

Results Reference

background

PubMed Identifier

33444116

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.

Results Reference

derived

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

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