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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

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.