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

NCT01327235 | Completed Phase 2

• 1 other identifier: SIM-90
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 3

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.

Conditions

Malignant Pleural Effusion; Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  WHO criteria

  baseline to measured progressive disease, every three weeks

Secondary Outcomes (3)

• 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

Study Arms (3)

Endostar

ACTIVE COMPARATOR

Drug: Endostar

Cisplatin

ACTIVE COMPARATOR

Drug: Cisplatin

Endostar and Cisplatin

EXPERIMENTAL

Drug: Endostar; Drug: Cisplatin

Interventions

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

Cisplatin DRUG

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

Cisplatin; Endostar and Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (3)

The 81st Hospital of Chinese PLA

Nanjing, China

Location

The Affiliated Hospital of Medical College, QingDao University

Qingdao, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

endostar protein; Cisplatin

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Shukui Qin, MD

  The 81st Hospital of Chinese PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: April 1, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

CN (3)