A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer

Phase 2

• Conditions: Small Cell Lung Cancer
• Interventions: Device: Liposomal Doxorubicin Combined With ifosfamide

• Registration Number: NCT01872416
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-05-17
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18
• Primary Completion: 2014-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refractory and relapsed SCLC	Liposomal Doxorubicin Combined With ifosfamide	Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer

Primary Outcome Measures

Name	Time	Method
objective response rate	From date of randomization until the date of progression, assessed up to 5 months	participants will be followed for the duration of hospital stay, an expected average of 5 months

Secondary Outcome Measures

Name	Time	Method
progression free survival(PFS）	From date of randomization until the date of progression, assessed up to 5 months

Trial Locations

Locations (1)

he First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China