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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00660504
First received: April 10, 2008
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Amrubicin Hydrochloride
Drug: Etoposide-Cisplatin combined chemotherapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1.5 years after last subject enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 1.5 years after last subject enrolled ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: participants were followed for the duration of the study, an average of 12 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Overall Survival at 6 and 12 Months [ Time Frame: 6 and 12 months. ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: April 2008
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Drug: Amrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
Active Comparator: 2
Etoposide-Cisplatin combined chemotherapy
Drug: Etoposide-Cisplatin combined chemotherapy
combined chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660504

Locations
China, Fujian
Fuzhou, Fujian, China
China, Gansu
Lanzhou, Gansu, China
China, Guangdong
Guangzhou, Guangdong, China
China, Hunan
Changsha, Hunan, China
China, Jiangsu
Nanjing, Jiangsu, China
China, Jiangxi
Nanchang, Jiangxi, China
China, Jilin
Changchun, Jilin, China
China, Liaoning
Dalian/Shenyang, Liaoning, China
Shenyang, Liaoning, China
China, Shanxi
Xian, Shanxi, China
China, Sichuan
Chengdu, Sichuan, China
China, Zhejiang
Hangzhou, Zhejiang, China
China
Beijing, China
Shanghai, China
Tianjin, China
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Investigators
Principal Investigator: Yan Sun, MD Cancer hospital, Chinese Academy of Medical Science
  More Information

No publications provided

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT00660504     History of Changes
Other Study ID Numbers: D0750018, D0750018
Study First Received: April 10, 2008
Results First Received: November 21, 2013
Last Updated: July 9, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
Extensive Disease-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Amrubicin
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014