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Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients With Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy

NCT00319969•Celgene Corporation

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the objective tumor response rate of amrubicin or standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who have chemotherapy sensitive recurrent or progressive.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological or cytological diagnosis of SCLC
•Extensive disease (ED) at time of study entry
•Response to first-line platinum-based chemotherapy
•Recurrent or progressive SCLC ≥90 days after completion of first-line therapy
•At least 18 years of age
•ECOG Performance Status of 0, 1, or 2
•Measurable disease defined by RECIST criteria
•* Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.
•* Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm using spiral CT scans.
•CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the leions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (eg., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
+7 more criteria

Exclusion Criteria

•Pregnant or nursing women
•Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to \<25% of the bone marrow.
•More than 1 prior chemotherapy regimen for SCLC
•Prior anthracycline treatment
•Participation in any investigational drug study within 28 days prior to study entry
•Patients with second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence; prior low grade \[Gleason score ≤6\] localized prostate cancer is allowed)
•Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
•Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for ≥2 weeks and off corticosteroids for ≥1 week.
•History of interstitial lung disease or pulmonary fibrosis

Locations (47)

Birmingham Hematology & Oncology

Birmingham, Alabama, United States

Hematology Oncology Associates

Phoenix, Arizona, United States

Alta Bates Medical Center - Comprehensive Cancer Center

Berkeley, California, United States

Moores UCSD Cancer Center

La Jolla, California, United States

Rocky Mountain Cancer Center - Denver

Denver, Colorado, United States

Rocky Mountain Cancer Center - Sky Ridge

Lone Tree, Colorado, United States

Ocala Oncology Center

Ocala, Florida, United States

Cancer Centers of Florida, PA

Ocoee, Florida, United States

John B. Amos Cancer Center

Columbus, Georgia, United States

Cancer Care & Hematology Specialists of Chicago

Niles, Illinois, United States

Key Dates

Start Date

April 1, 2006

Primary Completion Date

July 1, 2008

Completion Date

January 1, 2009

Last Updated

September 30, 2009

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer

Interventions

Amrubicin

DRUG

Topotecan

DRUG

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NCT07190248

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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