Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00286169 |
Recruitment Status :
Terminated
First Posted : February 3, 2006
Last Update Posted : August 10, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small-cell Lung Cancer | Drug: Amrubicin Hydrochloride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
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 |
Study Start Date : | April 2006 |

- Overall survival
- Time to progression
- Objective tumor response
- Quality of Life (QOL: EuroQOL, FACT-L-LCS)
- Frequency and severity of adverse events

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, Learn About Clinical Studies.
Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00286169
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 |
Study Director: | Drug Development Division | Dainippon Sumitomo Pharma Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00286169 |
Other Study ID Numbers: |
D0702002 JapicCTI-060203 |
First Posted: | February 3, 2006 Key Record Dates |
Last Update Posted: | August 10, 2010 |
Last Verified: | August 2010 |
Extensive-disease small-cell lung cancer (ED-SCLC) |
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 |