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

• ClinicalTrials.gov Identifier: NCT01192230
• Recruitment Status: Unknown
• First Posted: September 1, 2010
• Last Update Posted: September 16, 2010
• Sponsor: Fudan University
• Information provided by: Fudan University

Tracking Information

• First Submitted Date: August 4, 2010
• First Posted Date: September 1, 2010
• Last Update Posted Date: September 16, 2010
• Study Start Date: June 2009
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2010)

• Response rate [ Time Frame: six weeks ]
• Progression free survival [ Time Frame: six weeks ]
• Overall survival [ Time Frame: three months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2010)

Quality of Life [ Time Frame: six weeks ]

EORTC QLQ-C30(v3.0)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
• Official Title: A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• Drug: Endostatins
  7.5mg/m2 qd *14d,q3w
• Drug: Docetaxel
  75mg/m2 D1, q3w,4-6cycles

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 31, 2010): 30
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01192230
• Other Study ID Numbers: EndoDocNSCLC
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
• Study Sponsor: Fudan University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jianhua Chang, MD,PhD; Fudan University affiliated cancer hospital

• PRS Account: Fudan University
• Verification Date: August 2010