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

Phase 2

• Conditions: Advanced Melanoma; Untreated Patients
• Interventions: Drug: dacarbazine plus Endostar (Experimental group); Drug: dacarbazine plus placebo (control group)

• Registration Number: NCT00813449
• Lead Sponsor: Simcere Pharmaceutical Co., Ltd

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Status Verified: 2009-11
• Last Update Submitted: 2009-12-06
• Last Update Posted: 2009-12-08
• Primary Completion: 2010-08
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	dacarbazine plus Endostar (Experimental group)	Experimental group : Endostar combined with dacarbazine
2	dacarbazine plus placebo (control group)	Control group : Dacarbazine combined with placebo

Primary Outcome Measures

Name	Time	Method
Progression-free survival time , Total survival time	2010.8

Secondary Outcome Measures

Name	Time	Method
Tumor response rate , Disease controlled rate and adverse effects	2009.8

Trial Locations

Locations (1)

Beijing tumor hospital; 🇨🇳 Beijing, Beijing, China