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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03095079
• Other study ID #: BCH-MM-
• Status: Recruiting
• Phase: Phase 2
• First received: March 20, 2017
• Last updated: March 23, 2017
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: March 2017
• Source: Beijing Cancer Hospital
• Contact: Chuanliang Cui, MD
• Phone: 0086-10-88196951
• Email: 1008ccl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• recombinant human endostatin
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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Cui C, Mao L, Chi Z, Si L, Sheng X, Kong Y, Li S, Lian B, Gu K, Tao M, Song X, Lin T, Ren X, Qin S, Guo J. A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma. Mol Ther. 2013 Jul;21(7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease control rate(DCR)	CR+PR+SD	From randomization up to 144 weeks
Secondary	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