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Completed

NCT Number: NCT01327235

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

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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Key information

Conditions

Malignant Pleural Effusion Malignant Ascites Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The 81st Hospital of Chinese PLA, Nanjing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endostar

Drug

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

Cisplatin

Drug

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

Primary outcomes

  1. Objective Response Rate

    Time frame: baseline to measured progressive disease, every three weeks

    WHO criteria

Secondary outcomes

  1. Time to Progression

    Time frame: baseline to every three weeks until disease progression

  2. Quality of Life

    Time frame: baseline to every three weeks

  3. Incidence of Adverse Events

    Time frame: Up to 1 month after the last treatment

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2011
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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