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

Primary Purpose

Melanoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

recombinant human endostatin

About this trial

This is an interventional treatment trial for Melanoma focused on measuring endostar, dacarbazine, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EDP

Arm Description

Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1~14

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease control rate(DCR)

CR+PR+SD

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

Full Information

NCT ID

NCT03095079

First Posted

March 20, 2017

Last Updated

March 23, 2017

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03095079

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

endostar, dacarbazine, cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EDP

Arm Type

Experimental

Arm Description

Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1~14

Intervention Type

Drug

Intervention Name(s)

recombinant human endostatin

Other Intervention Name(s)

endostar

Intervention Description

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

Primary Outcome Measure Information:

Title

progress-free survival(PFS)

Description

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 Outcome Measure Information:

Title

Disease control rate(DCR)

Description

CR+PR+SD

Time Frame

From randomization up to 144 weeks

Title

adverse events

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chuanliang Cui, MD

Phone

0086-10-88196951

1008ccl@163.com

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuanliang Cui, MD

Phone

+86 13691489319

12. IPD Sharing Statement

Citations:

PubMed Identifier

23670576

Citation

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):1456-63. doi: 10.1038/mt.2013.79. Epub 2013 May 14.

Results Reference

result

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

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