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

Simcere

Status and phase: Completed; Phase 2

Conditions: Malignant Ascites; Malignant Pleural Effusion

Treatments: Drug: Cisplatin; Drug: Endostar

Study type: Interventional

Funder types: Industry

Identifiers

NCT01327235

SIM-90

Details and patient eligibility

About

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.

Enrollment: 336 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

336 participants in 3 patient groups

Endostar

Active Comparator group

Treatment:

Drug: Endostar

Cisplatin

Active Comparator group

Treatment:

Drug: Cisplatin

Endostar and Cisplatin

Experimental group

Treatment:

Drug: Cisplatin

Drug: Endostar