Back to results

Safety Study of Combined Chemotherapy and Endostar to Untreated Patients With Advanced Melanoma (melanoma)

Primary Purpose

Advanced Melanoma, Untreated Patients

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

dacarbazine plus Endostar (Experimental group)

dacarbazine plus placebo (control group)

About this trial

This is an interventional treatment trial for Advanced Melanoma focused on measuring Endostar, advanced melanoma, combined chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years old, males or females;
Untreated patients with advanced melanoma confirmed by histopathology or cytology;
With tumor foci that can be evaluated by CT or MRI; at least one diameter ≥ 1 cm (including metastatic lymph nodes, diameter ≥ 1 cm confirmed by CT scan); or superficial focus ≥ 2 cm (confirmed by photos with calibration);
No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤2.5×UNL; Hepatic function: transaminase≤2.5×UNL, or ≤5×UNL in patients with liver metastasis;
Karnofsky performance scale≥70 (appendix 1); expected survival time≥3 months;
Patients are voluntary to participate and sign the informed contents.

Exclusion Criteria:

Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;
Have been treated by dacarbazine or dacarbazine included combination chemotherapy;
Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
Allergic to any drug in the trial;
Patients with a second tumor;
Patients participating in other clinical trials;
Other conditions that are regarded for exclusion by the trialists

Sites / Locations

Beijing tumor hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Experimental group : Endostar combined with dacarbazine

Control group : Dacarbazine combined with placebo

Outcomes

Primary Outcome Measures

Progression-free survival time , Total survival time

Secondary Outcome Measures

Tumor response rate , Disease controlled rate and adverse effects

Full Information

NCT ID

NCT00813449

First Posted

December 19, 2008

Last Updated

December 6, 2009

Sponsor

Simcere Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00813449

Brief Title

Safety Study of Combined Chemotherapy and Endostar to Untreated Patients With Advanced Melanoma

Acronym

melanoma

Official Title

Multicenter, Double-blinding, Randomized Controlled, Phase II Clinical Trial on Combined Chemotherapy of Endostar (Recombinant Human Endostatin) for Untreated Patients With Advanced Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2010 (Anticipated)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Simcere Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Multicenter, double-blinding, randomized controlled, phase II clinical trial on combined chemotherapy of Endostar (Recombinant Human Endostatin) for untreated patients with advanced melanoma, To compare the efficacy and safety of Endostar combined with Dacarbazine and monotherapy of Dacarbazine for advanced melanoma

Detailed Description

Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and as a single agent gives a response rate of about 20%. There have been efforts to ameliorate this poor result by using DTIC in different combinations without a significant improvement. In addition, new studies with melanoma cells in vitro show that DTIC combination with Endostar, suggesting a potential clinical benefit from the concomitant treatment of DTIC and antiangiogenesis therapy. Endostar is a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. The purpose of this study is to determine whether a combination therapy of endostar and DTIC is safe and can increase response rate and progression-free survival in patients (pts) with metastatic melanoma. We will evaluate the efficacy and safety of the Endostar plus DTIC and hope provide a new hope for the advanced melanoma patients.

6. Conditions and Keywords

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

Advanced Melanoma, Untreated Patients

Keywords

Endostar, advanced melanoma, combined chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Experimental group : Endostar combined with dacarbazine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Control group : Dacarbazine combined with placebo

Intervention Type

Drug

Intervention Name(s)

dacarbazine plus Endostar (Experimental group)

Other Intervention Name(s)

dacarbazine plus Endostar

Intervention Description

dacarbazine plus Endostar

Intervention Type

Drug

Intervention Name(s)

dacarbazine plus placebo (control group)

Other Intervention Name(s)

dacarbazine plus placebo

Intervention Description

dacarbazine plus placebo

Primary Outcome Measure Information:

Title

Progression-free survival time , Total survival time

Time Frame

2010.8

Secondary Outcome Measure Information:

Title

Tumor response rate , Disease controlled rate and adverse effects

Time Frame

2009.8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years old, males or females; Untreated patients with advanced melanoma confirmed by histopathology or cytology; With tumor foci that can be evaluated by CT or MRI; at least one diameter ≥ 1 cm (including metastatic lymph nodes, diameter ≥ 1 cm confirmed by CT scan); or superficial focus ≥ 2 cm (confirmed by photos with calibration); No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤2.5×UNL; Hepatic function: transaminase≤2.5×UNL, or ≤5×UNL in patients with liver metastasis; Karnofsky performance scale≥70 (appendix 1); expected survival time≥3 months; Patients are voluntary to participate and sign the informed contents. Exclusion Criteria: Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method; With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover; With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension; Have been treated by dacarbazine or dacarbazine included combination chemotherapy; Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response; Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders; Allergic to any drug in the trial; Patients with a second tumor; Patients participating in other clinical trials; Other conditions that are regarded for exclusion by the trialists

Central Contact Person:

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

Guo Jun, PI

Phone

13911233048

Ext

8610

1008ccl@163.com

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

Cui Ch Liang, Doctor

Phone

13691489319

Ext

8610

1008ccl@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guo Jun, PI

Organizational Affiliation

Expert Committee for Melanoma of CSCO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing tumor hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100036

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Guo, professor

Phone

8610-88121122

guoj307@126.com

First Name & Middle Initial & Last Name & Degree

liang ch Cui, doctor

Phone

8610-88121122

First Name & Middle Initial & Last Name & Degree

Jun Guo, professor

12. IPD Sharing Statement

Links:

URL

http://www.bjcancer.org/

Description

Related Info

Learn more about this trial

Safety Study of Combined Chemotherapy and Endostar to Untreated Patients With Advanced Melanoma

We'll reach out to this number within 24 hrs