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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Malignant Pleural Effusion, Malignant Ascites

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

WHO criteria

Outcome Time Frame:

baseline to measured progressive disease, every three weeks

Safety Issue:

No

Principal Investigator

Shukui Qin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The 81st Hospital of Chinese PLA

Authority:

China: Food and Drug Administration

Study ID:

SIM-90

NCT ID:

NCT01327235

Start Date:

March 2011

Completion Date:

February 2014

Related Keywords:

  • Malignant Pleural Effusion
  • Malignant Ascites
  • Ascites
  • Pleural Effusion
  • Pleural Effusion, Malignant

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