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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813449
Recruitment Status : Unknown
Verified November 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : December 23, 2008
Last Update Posted : December 8, 2009
Information provided by:
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

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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 2008
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine

Arm Intervention/treatment
Experimental: A
Experimental group : Endostar combined with dacarbazine
Drug: dacarbazine plus Endostar (Experimental group)
dacarbazine plus Endostar
Other Name: dacarbazine plus Endostar

Placebo Comparator: 2
Control group : Dacarbazine combined with placebo
Drug: dacarbazine plus placebo (control group)
dacarbazine plus placebo
Other Name: dacarbazine plus placebo

Primary Outcome Measures :
  1. Progression-free survival time , Total survival time [ Time Frame: 2010.8 ]

Secondary Outcome Measures :
  1. Tumor response rate , Disease controlled rate and adverse effects [ Time Frame: 2009.8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813449

Contact: Guo Jun, PI 13911233048 ext 8610
Contact: Cui Ch Liang, Doctor 13691489319 ext 8610

China, Beijing
Beijing tumor hospital Recruiting
Beijing, Beijing, China, 100036
Contact: Jun Guo, professor    8610-88121122   
Contact: liang ch Cui, doctor    8610-88121122      
Principal Investigator: Jun Guo, professor         
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Principal Investigator: Guo Jun, PI Expert Committee for Melanoma of CSCO

Additional Information:
Responsible Party: Guo Jun, Expert Committee for Melanoma of CSCO Identifier: NCT00813449     History of Changes
Other Study ID Numbers: simcere001
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: December 8, 2009
Last Verified: November 2009

Keywords provided by Simcere Pharmaceutical Co., Ltd:
advanced melanoma
combined chemotherapy

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas