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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00813449
First received: December 19, 2008
Last updated: December 6, 2009
Last verified: November 2009

December 19, 2008
December 6, 2009
August 2008
August 2010   (final data collection date for primary outcome measure)
Progression-free survival time , Total survival time [ Time Frame: 2010.8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00813449 on ClinicalTrials.gov Archive Site
Tumor response rate , Disease controlled rate and adverse effects [ Time Frame: 2009.8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Combined Chemotherapy and Endostar to Untreated Patients With Advanced Melanoma
Multicenter, Double-blinding, Randomized Controlled, Phase II Clinical Trial on Combined Chemotherapy of Endostar (Recombinant Human Endostatin) for Untreated Patients With Advanced Melanoma

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Advanced Melanoma
  • Untreated Patients
  • Drug: dacarbazine plus Endostar (Experimental group)
    dacarbazine plus Endostar
    Other Name: dacarbazine plus Endostar
  • Drug: dacarbazine plus placebo (control group)
    dacarbazine plus placebo
    Other Name: dacarbazine plus placebo
  • Experimental: A
    Experimental group : Endostar combined with dacarbazine
    Intervention: Drug: dacarbazine plus Endostar (Experimental group)
  • Placebo Comparator: 2
    Control group : Dacarbazine combined with placebo
    Intervention: Drug: dacarbazine plus placebo (control group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Guo Jun, PI 13911233048 ext 8610 1008ccl@163.com
Contact: Cui Ch Liang, Doctor 13691489319 ext 8610 1008ccl@163.com
China
 
NCT00813449
simcere001, simcere0801
Yes
Guo Jun, Expert Committee for Melanoma of CSCO
Simcere Pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Guo Jun, PI Expert Committee for Melanoma of CSCO
Simcere Pharmaceutical Co., Ltd
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP