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NCT Number: NCT01531790

A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients

This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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 inoperable stage IIIB/IV non-squamous NSCLC
  • At least one measurable lesion (RECIST criteria)
  • Life expectancy > 3 months
  • ECOG performance status 0-2
  • Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
  • Adequate renal, hepatic and coagulation function
  • Written informed consent

Exclusion criteria

  • With uncontrollable malignant pleural effusion or ascites
  • Thoracic or abdominal surgery within 28 days prior to study entry
  • History of cerebral stroke or TIA within 6 months prior to study entry
  • With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
  • Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (> NYHA class II)
  • With serious infection (> NCI CTC grade 2)
  • Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
  • Symptomatic brain metastases
  • Patient who has epilepsy
  • History of HIV infection or chronic hepatitis B or C
  • Allergic to any of the study drugs
  • Pregnant or lactating women

Treatment and study plan

carboplatin

Drug

d1, AUC 5, i.v.

Pemetrexed

Drug

d1, 500 mg/m2, i.v.

Endostar

Drug

d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.

Centrum

Drug

1 tablet/day

Primary outcomes

  1. Dose Limiting Toxicity

    Time frame: up to 21 days

Secondary outcomes

  1. Objective Response Rate

    Time frame: up to 6 cycles

  2. Disease Control Rate

    Time frame: up to 6 cycles

  3. Progression-free Survival

    Time frame: up to 2 years

  4. Overall Survival

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2012
Registry last updated
Jan 16, 2013

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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