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

Phase 2

• Conditions: Melanoma
• Interventions: Drug: recombinant human endostatin

• Registration Number: NCT03095079
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29
• Primary Completion: 2017-12
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EDP	recombinant human endostatin	Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1\~14

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China