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

NCT01872416 | Unknown Phase 2

• 2 other identifiers: FAHG20120926AFAHGuangzhou012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• objective response rate

  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 Outcomes (1)

• progression free survival(PFS）

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

Other Outcomes (1)

• overall survival

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

Study Arms (1)

Refractory and relapsed SCLC

EXPERIMENTAL

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

Device: Liposomal Doxorubicin Combined With ifosfamide

Interventions

Liposomal Doxorubicin Combined With ifosfamide DEVICE

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

Refractory and relapsed SCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

he First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• jianxing He, MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianxing He, MD

CONTACT

+86-20-83062808; hejx@vip.163.com

yalei Zhang, Master degree

CONTACT

+86-20-83062821; yayazhang2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Guangzhou Medical University

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: June 7, 2013
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

CN (1)