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

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ClinicalTrials.gov Identifier: NCT01872416
Recruitment Status : Unknown
Verified June 2013 by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
Jianxing He, 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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Device: Liposomal Doxorubicin Combined With ifosfamide Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2015


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. progression free survival(PFS) [ Time Frame: From date of randomization until the date of progression, assessed up to 5 months ]

Other Outcome Measures:
  1. overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872416


Contacts
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Contact: jianxing He, MD +86-20-83062808 hejx@vip.163.com
Contact: yalei Zhang, Master degree +86-20-83062821 yayazhang2004@163.com

Locations
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China, Guangdong
he First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jianxing He, MD    +86-20-83062808    hejx@vip.163.com   
Contact: Yalei Zhang, Master    +86-20-83062821    yayazhang2004@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: jianxing He, MD The First Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01872416     History of Changes
Other Study ID Numbers: FAHG20120926A
FAHGuangzhou012 ( Registry Identifier: FAHGuangzhou012 )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University:
Refractory and relapsed small cell lung cancer
Liposomal Doxorubicin
ifosfamide
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ifosfamide
Isophosphamide mustard
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents