Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)
A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar（rh Recombined Endostatin）With Single Docetaxel In NSCLC Patients
2 other identifiers
interventional
300
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJanuary 25, 2010
December 1, 2009
1 year
December 19, 2008
January 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival time,survival rate for 1 year
two years (2010.10)
Secondary Outcomes (1)
Tumor response rate, disease controlled rate and adverse effects.
1 year (2009.10)
Study Arms (2)
1
EXPERIMENTALEndostar combined with Docetaxel for Advanced NSCLC: All eligible patients will receive Endostar in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Endostar treatment will continue after completion of first 4 cycles until disease progression.
2
PLACEBO COMPARATORDocetaxel combined with placebo for Advanced NSCLC: All eligible patients will receive placebo in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Placebo will continue after completion of first 4 cycles until disease progression.
Interventions
7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- Age 18-75 years old, males or females;
- Patients with NSCLC confirmed by histopathology or cytology who need second-line chemotherapy, including progressive disease cases during or in 3 months posterior to end of first-line chemotherapy( at least 4 cycles done) and cases with intolerant adverse effects in first-line chemotherapy( at least 4 cycles done); neo-adjuvant chemotherapy and targeted therapy(EFGR-TKIs) not to be served as first-line chemotherapy; 3 months of clearance needed for neo-adjuvant chemotherapy and 1 month for targeted and first-line chemotherapy;
- Local advanced and metastatic cases with tumor foci that can be evaluated by CT, MRI or PET-CT; at least one diameter ≥ 1 cm (including metastatic lymph nodes) confirmed by CT scan or ≥ 1 cm by spin CT or PET-CT );
- No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤1.0×UNL; Hepatic function: transaminase≤1.5×UNL, BIL≤×UNL;
- Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3 months;
- No allergic history to biological agents and taxane agents;
- Patients are voluntary to participate and sign the informed contents.
You may not qualify if:
- Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
- With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
- With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;
- Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
- Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
- Uncontrolled diabetes and contraindication to corticoid agents;
- Obvious hemorrhage tendency;
- Allergic to any drug in the trial;
- Patients with a second tumor;
- Patients participating in other clinical trials;
- Patients treated by Endostar or Docetaxel (excluding neo-chemotherapy) included combination chemotherapy previously;
- Foci to be evaluated for response in trial treated by radiation in 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital of Tianjin Medical University
Tianjin, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai LI, professor
Cancer Hospital of Tianjin Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 23, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2010
Last Updated
January 25, 2010
Record last verified: 2009-12