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

June 17, 2013 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • he First Affiliated Hospital of Guangzhou Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Refractory and relapsed SCLC
Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer
Device: Liposomal Doxorubicin Combined With ifosfamide
Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 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
From date of randomization until the date of progression, assessed up to 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival(PFS）
Time Frame: From date of randomization until the date of progression, assessed up to 5 months
From date of randomization until the date of progression, assessed up to 5 months

Other Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 months
From date of randomization until the date of death from any cause, assessed up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAHG20120926A
  • FAHGuangzhou012 (Registry Identifier: FAHGuangzhou012)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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