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

A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01192230

Enrollment

Registered

2010-09-01

Start date

2009-06-30

Completion date

Unknown

Last updated

2010-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity

Brief summary

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.

Interventions

DRUGEndostatins

7.5mg/m2 qd \*14d,q3w

DRUGDocetaxel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate	six weeks
Progression free survival	six weeks
Overall survival	three months

Secondary

Measure	Time frame	Description
Quality of Life	six weeks	EORTC QLQ-C30(v3.0)

Countries

China

Contacts

Primary ContactJianhua Chang, MD,PhD

changjianhua@hotmail.com13916619284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026