Endostar and/or Cisplatin for Treatment of Malignant Pleu... | NCT01327235

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

NCT01327235

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Aug 1, 2014Estimated

Enrollment

336Actual

Phase

Phase 2

Conditions

Malignant Pleural Effusion
Malignant Ascites

Interventions

Endostar
Cisplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Apr 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Mar 31, 2011

First Posted Date

Apr 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2014

Last Update Posted Date

Aug 1, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

336Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Endostar	Active Comparator	Drug: Endostar
Cisplatin	Active Comparator	Drug: Cisplatin
Endostar and Cisplatin	Experimental	Drug: Endostar Drug: Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endostar	Drug	intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles	Endostar Endostar and Cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate	WHO criteria	baseline to measured progressive disease, every three weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to Progression		baseline to every three weeks until disease progression
Quality of Life		baseline to every three weeks
Incidence of Adverse Events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shukui Qin, MD	The 81st Hospital of Chinese PLA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The 81st Hospital of Chinese PLA		Nanjing			China
The Affiliated Hospital of Medical College, QingDao University

Condition Browse Module

MeSH Terms

ID	Term
D016066	Pleural Effusion, Malignant

Ancestor Terms

ID	Term
D010997	Pleural Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522911	endostar protein
D002945	Cisplatin

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided