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


Phase 1
18 Years
70 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity

Outcome Time Frame:

up to 21 days

Safety Issue:

Yes

Principal Investigator

Li Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

SIM-93

NCT ID:

NCT01531790

Start Date:

September 2011

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Endostar
  • Carboplatin
  • Pemetrexed
  • NSCLC
  • Phase I
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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