Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Fudan University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192230
First received: August 4, 2010
Last updated: September 15, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Endostatins Drug: Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Docetaxel
U.S. FDA Resources
Further study details as provided by Fudan University:
Primary Outcome Measures:
- Response rate [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
- Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: three months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]EORTC QLQ-C30(v3.0)
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Endostatins
7.5mg/m2 qd *14d,q3w
Drug: Docetaxel
75mg/m2 D1, q3w,4-6cycles
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192230
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192230
Contacts
| Contact: Jianhua Chang, MD,PhD | 13916619284 | changjianhua@hotmail.com |
Locations
| China, Shanghai | |
| Cancer hospital Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Jianhua Chang, MD,PhD 13916619284 changjianhua@hotmail.com | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Jianhua Chang, MD,PhD | Fudan University affiliated cancer hospital |
More Information
No publications provided
| Responsible Party: | Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01192230 History of Changes |
| Other Study ID Numbers: | EndoDocNSCLC |
| Study First Received: | August 4, 2010 |
| Last Updated: | September 15, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Fudan University:
|
Objective response rate Disease control rate Disease free survival Overall survival |
Quality of Live Nonsmall cell lung cancer toxicity |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015