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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: recombinant human endostatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP<br>Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1 14 | Drug: recombinant human endostatin<br>* Cisplatin:dose was based on patient's weight and could be adjusted for weight change,75 mg/m^2 by IV infusion separated in 3 different days Dacarbazine:250mg/m2,administered by intravenous (IV) infusion on the 1 to 5 day of each cycle Hr-endostatin:dose based on body surface area as 15mg/m2,continuous intravenous infusion from day 1 to day 14<br>* Other names: endostar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate(DCR) | CR+PR+SD | From randomization up to 144 weeks | 
| adverse events | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dacarbazine, endostar, cisplatin