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

Peking University Cancer Hospital & Institute70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

recombinant human endostatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: From randomization up to 144 weeks

Secondary Outcomes

Disease control rate(DCR)

CR+PR+SD

Time frame: 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

Time frame: From randomization up to 144 weeks

Central Contacts

Chuanliang Cui, MD

CONTACT

0086-10-88196951 1008ccl@163.com

Data from ClinicalTrials.gov

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