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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Pleural Effusion Malignant Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endostar

Group Type ACTIVE_COMPARATOR

Endostar

Intervention Type DRUG

intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

Cisplatin

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

Endostar and Cisplatin

Group Type EXPERIMENTAL

Endostar

Intervention Type DRUG

intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

Cisplatin

Intervention Type DRUG

cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

Interventions

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Endostar

intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

Intervention Type DRUG

Cisplatin

cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No