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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02023710
• Other study ID #: BCH-MM-131101
• Status: Recruiting
• Phase: Phase 2
• First received: December 19, 2013
• Last updated: May 7, 2017
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Beijing Cancer Hospital
• Contact: Xinan Sheng, MD
• Phone: 0086-10-88196951
• Email: doctor_sheng[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Yunan Tumor Hospital	Kunming

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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-a2b 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomization up to 144 weeks
Secondary	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	From randomization up to144 weeks
Secondary	Overall Survival(OS)	Overall survival was defined as the time from randomization to death from any cause.	Up to 144 weeks