Clinical trial NCT01872416: A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer
Official title: A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer: Single Center, Single-arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Refractory and relapsed small cell lung cancer
Liposomal Doxorubicin
ifosfamide
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 cell lung cancer currently being explored, Anthracycline antibiotics is a cell cycle non-specific anticancer drugs could inhibit the synthesis of DNA, DNA and dependent RNA, its wide antitumor spectrum, widely used in malignant hematologic diseases and lung cancer and other solid tumors. Jacot W, et al evaluated epirubicin combined with ifosfamide (EI) for treatment of refractory and recurrent SCLC in 70 cases, the objective response rate (ORR) reached 21.4%, including 1 cases of complete remission, 10% other patients obtained stable disease (SD), all the patients had a median survival of 3.9 months, most (71%) patients with neutropenia, platelet count and anemia are also common, showed that EI treatment of refractory and relapsed SCLC is effectively controlled, toxicity.

In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may obtain better tumor remission rate, improve the prognosis of the patients.

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 doxorubicin and ifosfamide We will evaluate the progression-free survival (PFS) and overall survival (OS) i in receiving first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide

Eligibility criteria: Inclusion Criteria:

1. Male or female patients \>=18 years of age
2. the histological diagnosis of small cell lung cancer;
3. Patients who had first-line treatment failure or relapse after first-line therapy;
4. enough tumor tissue specimens for molecular marker analysis;
5. Measurable disease by RECIST criteria
6. ECOG performance status of \<=2.
7. Life expectancy of at least 3 months.
8. 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
9. Patient must be accessible for treatment and follow-up
10. All patients must be able to understand the nature of the study and give written informed consent prior to study entry

Exclusion Criteria:

1. mixed small cell lung cancer;
2. patients had a previous diagnosis of malignant tumor;
3. HIV infection;
4. 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.
5. patients had the motor or sensory neurons lesions/symptoms of NCI - CTC AE \> 1;
6. patients had serious active infections;
7. patients were allergic to ifosfamide or liposomal doxorubicin

Primary outcomes:
measure: objective response rate
timeFrame: From date of randomization until the date of progression, assessed up to 5 months
Secondary outcomes:
measure: progression free survival(PFS）
timeFrame: From date of randomization until the date of progression, assessed up to 5 months
Other outcomes:
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 10 months
Locations:
city: Guangzhou
country: China
facility: he First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: jianxing He, MD
role: PRINCIPAL_INVESTIGATOR
References: