Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

NCT ID: NCT01192230

Last Updated: 2010-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Endostatins

7.5mg/m2 qd \*14d,q3w

Intervention Type DRUG

Docetaxel

75mg/m2 D1, q3w,4-6cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
* ≥ 18 years old
* patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
* At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
* have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
* ECOG 0-2
* Expected life time longer than 3 months
* Normal laboratory values:

* leucocyte≥ 4×109/L
* neutrophil≥ 1.5×109/L
* platelet≥90×109/L
* Hemoglobin≥ 9g/L
* ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
* serum creatinine\<1.5 mg/dl
* bilirubin \<1.5×ULN
* No allergy to biological drug
* Sign the consent forms

Exclusion Criteria

* Patients who have previously received Docetaxel or anti-VEGF inhibitors
* Severe symptomatic heart disease
* Female patients during their pregnant and lactation period, or patients without contraception
* Severe uncontrolled infection
* Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
* Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
* Patients have accepted other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Department of Medical Oncology,Fudan University Cancer Hospital

Principal Investigators

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Jianhua Chang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University affiliated cancer hospital

Locations

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Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhua Chang, MD,PhD

Role: CONTACT

13916619284

Facility Contacts

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Jianhua Chang, MD,PhD

Role: primary

13916619284

Other Identifiers

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EndoDocNSCLC

Identifier Type: -

Identifier Source: org_study_id