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

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Liposomal Doxorubicin Combined With ifosfamide

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Refractory and relapsed small cell lung cancer, Liposomal Doxorubicin, ifosfamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

he First Affiliated Hospital of Guangzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Refractory and relapsed SCLC

Arm Description

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

Outcomes

Primary Outcome Measures

objective response rate

participants will be followed for the duration of hospital stay, an expected average of 5 months

Secondary Outcome Measures

progression free survival(PFS）

Full Information

NCT ID

NCT01872416

First Posted

May 17, 2013

Last Updated

June 17, 2013

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01872416

Brief Title

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

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

May 2014 (Anticipated)

Study Completion Date

May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

Refractory and relapsed small cell lung cancer, Liposomal Doxorubicin, ifosfamide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Refractory and relapsed SCLC

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Liposomal Doxorubicin Combined With ifosfamide

Intervention Description

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

Primary Outcome Measure Information:

Title

objective response rate

Description

participants will be followed for the duration of hospital stay, an expected average of 5 months

Time Frame

From date of randomization until the date of progression, assessed up to 5 months

Secondary Outcome Measure Information:

Title

progression free survival(PFS）

Time Frame

From date of randomization until the date of progression, assessed up to 5 months

Other Pre-specified Outcome Measures:

Title

overall survival

Time Frame

From date of randomization until the date of death from any cause, assessed up to 10 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jianxing He, MD

Phone

+86-20-83062808

hejx@vip.163.com

First Name & Middle Initial & Last Name or Official Title & Degree

yalei Zhang, Master degree

Phone

+86-20-83062821

yayazhang2004@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jianxing He, MD

Organizational Affiliation

The First Affiliated Hospital of Guangzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

he First Affiliated Hospital of Guangzhou Medical College

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianxing He, MD

Phone

+86-20-83062808

hejx@vip.163.com

First Name & Middle Initial & Last Name & Degree

Yalei Zhang, Master

Phone

+86-20-83062821

yayazhang2004@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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