Safety Study of Combined Chemotherapy and Endostar to Untreated Patients With Advanced Melanoma (melanoma)
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Melanoma Untreated Patients | Drug: dacarbazine plus Endostar (Experimental group) Drug: dacarbazine plus placebo (control group) | Phase 2 |
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 |

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
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Placebo Comparator: 2
Control group : Dacarbazine combined with placebo
|
Drug: dacarbazine plus placebo (control group)
dacarbazine plus placebo
Other Name: dacarbazine plus placebo
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- Progression-free survival time , Total survival time [ Time Frame: 2010.8 ]
- Tumor response rate , Disease controlled rate and adverse effects [ Time Frame: 2009.8 ]

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

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 ClinicalTrials.gov identifier (NCT number): NCT00813449
Contact: Guo Jun, PI | 13911233048 ext 8610 | 1008ccl@163.com | |
Contact: Cui Ch Liang, Doctor | 13691489319 ext 8610 | 1008ccl@163.com |
China, Beijing | |
Beijing tumor hospital | Recruiting |
Beijing, Beijing, China, 100036 | |
Contact: Jun Guo, professor 8610-88121122 guoj307@126.com | |
Contact: liang ch Cui, doctor 8610-88121122 | |
Principal Investigator: Jun Guo, professor |
Principal Investigator: | Guo Jun, PI | Expert Committee for Melanoma of CSCO |
Additional Information:
Responsible Party: | Guo Jun, Expert Committee for Melanoma of CSCO |
ClinicalTrials.gov Identifier: | NCT00813449 History of Changes |
Other Study ID Numbers: |
simcere001 simcere0801 |
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:
Endostar advanced melanoma combined chemotherapy |
Additional relevant MeSH terms:
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |