Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660504
• Other study ID #: D0750018
• Secondary ID: D0750018
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2008
• Last updated: July 9, 2014
• Start date: April 2008
• Est. completion date: August 2012

Study information

• Verified date: July 2014
• Source: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically/cytologically proven small cell lung cancer

• Extensive disease

• No prior chemotherapy regimen

• Age 18 years or older

• ECOG performance status of 0-1

Exclusion Criteria:

• Brain metastasis requiring treatment

• Treatment (Surgical or radiotherapy)of primary tumor

• Interstitial pneumonia or pulmonary fibrosis

• Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Amrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
• Etoposide-Cisplatin combined chemotherapy
combined chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival at 6 and 12 Months		6 and 12 months.	No
Primary	Overall Survival		1.5 years after last subject enrolled	No
Secondary	Progression-Free Survival		1.5 years after last subject enrolled	No
Secondary	Objective Response Rate	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	participants were followed for the duration of the study, an average of 12 weeks	No