Status:
UNKNOWN
A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
At present, there is no standard second-line treatment of refractory and relapsed SCLC, topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line treatment of small...
Detailed Description
the investigators will evaluate the overall response rate (complete and partial responses) in first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal dox...
Eligibility Criteria
Inclusion
- Male or female patients \>=18 years of age
- the histological diagnosis of small cell lung cancer;
- Patients who had first-line treatment failure or relapse after first-line therapy;
- enough tumor tissue specimens for molecular marker analysis;
- Measurable disease by RECIST criteria
- ECOG performance status of \<=2.
- Life expectancy of at least 3 months.
- Laboratory values as follows:: ANC ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; HB ≥ 90g/L; serum bilirubin ≤ 1.5 upper limit of normal (N); ALT/AST≤ 2N (in patients with liver metastases :ALT/AST≤ 5N) creatinine≤1.25 N;and clearance rate of creatinine ≥ 60mLl/min; proteinuria \< 2+, or were detected in 24 hour urine protein, protein content is ≤1g
- Patient must be accessible for treatment and follow-up
- All patients must be able to understand the nature of the study and give written informed consent prior to study entry
Exclusion
- mixed small cell lung cancer;
- patients had a previous diagnosis of malignant tumor;
- HIV infection;
- A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of \> grade 2 per New York Heart Association (NYHA) criteria, myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
- patients had the motor or sensory neurons lesions/symptoms of NCI - CTC AE \> 1;
- patients had serious active infections;
- patients were allergic to ifosfamide or liposomal doxorubicin
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01872416
Start Date
October 1 2012
End Date
May 1 2015
Last Update
June 18 2013
Active Locations (1)
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1
he First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120