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

NCT ID: NCT00813449

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Advanced Melanoma Untreated Patients

Keywords

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Endostar advanced melanoma combined chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Experimental group : Endostar combined with dacarbazine

Group Type EXPERIMENTAL

dacarbazine plus Endostar (Experimental group)

Intervention Type DRUG

dacarbazine plus Endostar

2

Control group : Dacarbazine combined with placebo

Group Type PLACEBO_COMPARATOR

dacarbazine plus placebo (control group)

Intervention Type DRUG

dacarbazine plus placebo

Interventions

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dacarbazine plus Endostar (Experimental group)

dacarbazine plus Endostar

Intervention Type DRUG

dacarbazine plus placebo (control group)

dacarbazine plus placebo

Intervention Type DRUG

Other Intervention Names

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dacarbazine plus Endostar dacarbazine plus placebo

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years old, males or females;
2. Untreated patients with advanced melanoma confirmed by histopathology or cytology;
3. 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);
4. 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;
5. Karnofsky performance scale≥70 (appendix 1); expected survival time≥3 months;
6. Patients are voluntary to participate and sign the informed contents.

Exclusion Criteria

1. Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
2. With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
3. 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;
4. Have been treated by dacarbazine or dacarbazine included combination chemotherapy;
5. Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
6. Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
7. Allergic to any drug in the trial;
8. Patients with a second tumor;
9. Patients participating in other clinical trials;
10. Other conditions that are regarded for exclusion by the trialists
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role lead

Responsible Party

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Expert Committee for Melanoma of CSCO

Principal Investigators

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Guo Jun, PI

Role: PRINCIPAL_INVESTIGATOR

Expert Committee for Melanoma of CSCO

Locations

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Beijing tumor hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo Jun, PI

Role: CONTACT

Phone: 13911233048

Email: [email protected]

Cui Ch Liang, Doctor

Role: CONTACT

Phone: 13691489319

Email: [email protected]

Facility Contacts

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Jun Guo, professor

Role: primary

liang ch Cui, doctor

Role: backup

Related Links

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http://www.bjcancer.org/

Related Info

Other Identifiers

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simcere0801

Identifier Type: -

Identifier Source: secondary_id

simcere001

Identifier Type: -

Identifier Source: org_study_id