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

Sponsor

Simcere Pharmaceutical Co., Ltd (Other)

Overall Status

Unknown status

CT.gov ID

NCT00813449

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Melanoma Untreated Patients	Drug: dacarbazine plus Endostar (Experimental group) Drug: dacarbazine plus placebo (control group)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2008

Anticipated Primary Completion Date :

Aug 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Experimental group : Endostar combined with dacarbazine	Drug: dacarbazine plus Endostar (Experimental group) dacarbazine plus Endostar Other Names: dacarbazine plus Endostar
Placebo Comparator: 2 Control group : Dacarbazine combined with placebo	Drug: dacarbazine plus placebo (control group) dacarbazine plus placebo Other Names: dacarbazine plus placebo

Arm

Intervention/Treatment

Experimental: A

Experimental group : Endostar combined with dacarbazine

Drug: dacarbazine plus Endostar (Experimental group)

dacarbazine plus Endostar

Other Names:

dacarbazine plus Endostar

Placebo Comparator: 2

Control group : Dacarbazine combined with placebo

Drug: dacarbazine plus placebo (control group)

dacarbazine plus placebo

Other Names:

dacarbazine plus placebo

Outcome Measures

Primary Outcome Measures

Progression-free survival time , Total survival time [2010.8]

Secondary Outcome Measures

Tumor response rate , Disease controlled rate and adverse effects [2009.8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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