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

Phase 2

Completed

• Conditions: Malignant Ascites; Malignant Pleural Effusion
• Interventions: Drug: Cisplatin; Drug: Endostar

• Registration Number: NCT01327235
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Primary Completion: 2014-04
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin	Cisplatin	-
Endostar	Endostar	-
Endostar and Cisplatin	Cisplatin	-
Endostar and Cisplatin	Endostar	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	baseline to measured progressive disease, every three weeks	WHO criteria

Secondary Outcome Measures

Name	Time	Method
Time to Progression	baseline to every three weeks until disease progression
Quality of Life	baseline to every three weeks
Incidence of Adverse Events	Up to 1 month after the last treatment

Trial Locations

Locations (3)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

The Affiliated Hospital of Medical College, QingDao University; 🇨🇳 Qingdao, China

The 81st Hospital of Chinese PLA; 🇨🇳 Nanjing, China