Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

a Phase II Trial With Continuous Intravenous Infusion of Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.

Inclusion Criteria:

• 1. Histologically confirmed melanoma with metastases and has no received any systemic treatment.
• 2.At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
• 3.Estimated life expectancy of 12 weeks or greater
• 4. ECOG performance status 0, 1
• 5.Adequate organ function
• 6.Without symptoms of brain metastases and stable in neuro-functions

Exclusion Criteria:

• 1. Pregnant or lactation women
• 2. Acute infections without control.
• 3. Heart disease history, cardiac function class≥NYHA II.
• 4. HIV positive or chronic HBV/HCV in active stage.
• 5. Brain metastases or primary tumor with positive symptoms
• 6. Need anti-epileptic treatments
• 7. Organ transplantation history
• 8. Hemorrhagic tendency or related history
• 9. Renal dialysis patients
• 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
• 11. Current treatment on another clinical trial
• 12. The other improper situations which investigator judged.