Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites

Malignant Pleural Effusion Clinical Trial

Official title:

A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327235
• Other study ID #: SIM-90
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2011
• Last updated: July 31, 2014
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histological or cytological diagnosis of thoracic or abdominal tumor

• At least medium amount of malignant pleural effusion or ascites

• ECOG Performance Status 0-2

• Life expectancy = 2 months

• Adequate hematologic, cardiac, renal, and hepatic function

• No major surgery within 4 weeks prior to this study

• Written informed consent

Exclusion Criteria:

• Patients with central nervous system (CNS) metastases

• Evidence of bleeding diathesis, serious infection

• Evidence of myocardial infarction, unstable angina or cardiac insufficiency

• Presence of serious COPD and/or respiratory failure

• Allergic to study drug

• Pregnant or lactating women

• Participation in other clinical trials within 30 days prior to this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites
• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Endostar
intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1?d4?d7), 3 times as one cycle, at most 2 cycles
• Cisplatin
cisplatin 40 mg, q3d ×3(d1?d4?d7), 3 times as one cycle, at most 2 cycles

Locations

Country	Name	City	State
China	The 81st Hospital of Chinese PLA	Nanjing
China	The Affiliated Hospital of Medical College, QingDao University	Qingdao
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	WHO criteria	baseline to measured progressive disease, every three weeks	No
Secondary	Time to Progression		baseline to every three weeks until disease progression	No
Secondary	Quality of Life		baseline to every three weeks	No
Secondary	Incidence of Adverse Events		Up to 1 month after the last treatment	Yes