Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
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ClinicalTrials.gov Identifier: NCT01192230 |
Recruitment Status : Unknown
Verified August 2010 by Fudan University.
Recruitment status was: Recruiting
First Posted : September 1, 2010
Last Update Posted : September 16, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung | Drug: Endostatins Drug: Docetaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | December 2011 |

- Drug: Endostatins
7.5mg/m2 qd *14d,q3w
- Drug: Docetaxel
75mg/m2 D1, q3w,4-6cycles
- Response rate [ Time Frame: six weeks ]
- Progression free survival [ Time Frame: six weeks ]
- Overall survival [ Time Frame: three months ]
- Quality of Life [ Time Frame: six weeks ]EORTC QLQ-C30(v3.0)

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192230
Contact: Jianhua Chang, MD,PhD | 13916619284 | changjianhua@hotmail.com |
China, Shanghai | |
Cancer hospital Fudan University | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Jianhua Chang, MD,PhD 13916619284 changjianhua@hotmail.com |
Principal Investigator: | Jianhua Chang, MD,PhD | Fudan University affiliated cancer hospital |
Responsible Party: | Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT01192230 |
Other Study ID Numbers: |
EndoDocNSCLC |
First Posted: | September 1, 2010 Key Record Dates |
Last Update Posted: | September 16, 2010 |
Last Verified: | August 2010 |
Objective response rate Disease control rate Disease free survival Overall survival |
Quality of Live Nonsmall cell lung cancer toxicity |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Docetaxel |
Endostatins Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |