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

NCT ID: NCT01872416

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-05-31

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

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Refractory and relapsed SCLC

Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer

Group Type: EXPERIMENTAL

Liposomal Doxorubicin Combined With ifosfamide

Intervention Type: DEVICE

Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer

Interventions

Liposomal Doxorubicin Combined With ifosfamide

Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianxing He

The First Affiliated Hospital of Guangzhou Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jianxing He, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

he First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

jianxing He, MD

Role: CONTACT

hejx@vip.163.com

+86-20-83062808

yalei Zhang, Master degree

Role: CONTACT

yayazhang2004@163.com

+86-20-83062821

Facility Contacts

Jianxing He, MD

Role: primary

hejx@vip.163.com

+86-20-83062808

Yalei Zhang, Master

Role: backup

yayazhang2004@163.com

+86-20-83062821

Other Identifiers

FAHGuangzhou012

Identifier Type: REGISTRY

Identifier Source: secondary_id

FAHG20120926A

Identifier Type: -

Identifier Source: org_study_id