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A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer: Single Center, Single-arm Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer: Single Center, Single-arm Study


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective response rate

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

jianxing He, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Affiliated Hospital of Guangzhou Medical University

Authority:

United States: Food and Drug Administration

Study ID:

FAHG20120926A

NCT ID:

NCT01872416

Start Date:

October 2012

Completion Date:

May 2015

Related Keywords:

  • Small Cell Lung Cancer
  • Refractory and relapsed small cell lung cancer
  • Liposomal Doxorubicin
  • ifosfamide
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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