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Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
This study has been terminated.
Sponsor:
Sumitomo Dainippon Pharma Co., Ltd.
Information provided by:
Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00286169
First received: February 1, 2006
Last updated: August 9, 2010
Last verified: August 2010
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Purpose
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Small-cell Lung Cancer | Drug: Amrubicin Hydrochloride | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:
Eligibility| Ages Eligible for Study: | 70 Years and older (Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Extensive-disease small-cell lung cancer
- Aged 70 years or older
- Performance status of 0-2
- No prior chemotherapy
Exclusion Criteria:
- Prior therapy for primary lesion
- Pneumonitis and/or pulmonary fibrosis
- Active concomitant malignancy
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: NCT00286169
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286169
Locations
| Japan | |
| Chubu Region Site | |
| Chubu, Japan | |
| Chugoku Region Site | |
| Chugoku, Japan | |
| Hokkaido Region Site | |
| Hokkaido, Japan | |
| Kanto Region Site | |
| Kanto, Japan | |
| Kinki Region Site | |
| Kinki, Japan | |
| Kyushu Region Site | |
| Kyushu, Japan | |
| Shikoku Region Site | |
| Shikoku, Japan | |
| Tohoku Region Site | |
| Tohoku, Japan | |
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
| Study Director: | Drug Development Division | Dainippon Sumitomo Pharma Co., Ltd. |
More Information
| ClinicalTrials.gov Identifier: | NCT00286169 History of Changes |
| Other Study ID Numbers: |
D0702002 JapicCTI-060203 |
| Study First Received: | February 1, 2006 |
| Last Updated: | August 9, 2010 |
Keywords provided by Sumitomo Dainippon Pharma Co., Ltd.:
|
Extensive-disease small-cell lung cancer (ED-SCLC) |
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 Amrubicin Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 20, 2017