Melanoma
Conditions
Keywords
endostar, dacarbazine, cisplatin
Brief summary
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.
Interventions
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
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress-free survival(PFS) | From randomization up to 144 weeks | Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate(DCR) | From randomization up to 144 weeks | CR+PR+SD |
| adverse events | From randomization up to 144 weeks | Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause |
Countries
China
Contacts
Primary ContactChuanliang Cui, MD
Outcome results
None listed