AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Completed · Phase 3

Conditions studied: Small Cell Lung Cancer

In brief

This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

Key facts

Study ID

NCT00547651

Run by

Celgene

People needed

637

Starts

2007-09-01

Expected to finish

2011-05-01

Last updated by the study team

2019-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
• SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression >/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression < 90 days after completing first-line chemotherapy);
• Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
• Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
• No more than 1 prior chemotherapy regimen;
• At least 18 years of age;
• ECOG performance status of 0 - 1

You may not qualify if…

• Chest radiotherapy with curative intent to the primary disease complex </= 28 days prior to first dose; CNS radiotherapy </= 21 days prior to first dose; radiotherapy to all other areas </= 7 days prior to first dose;
• Prior anthracycline, topotecan, or irinotecan treatment.
• Prior anthracycline or topotecan treatment.
• Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• Little Rock Hematology Oncology Associates — Little Rock, Arkansas, United States
• Cancer Care Associates of Fresno Medical Group, Inc. — Fresno, California, United States
• Cedars-Sinai Outpatient Cancer Center — Los Angeles, California, United States
• University of Colorado Health Science Centre — Aurora, Colorado, United States
• Rocky Mountain Cancer Center - Midtown (Main) — Denver, Colorado, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Cancer Centers of Florida, P.A. — Ocoee, Florida, United States
• Florida Oncology Associates — Orange Park, Florida, United States
• Sacred Heart Medical Oncology — Pensacola, Florida, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Cancer & Hematology Specialists of Chicago (Main) — Niles, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Cancer Care at Blessing Hospital — Quincy, Illinois, United States
• Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• Hope Center — Terre Haute, Indiana, United States
• Kansas City Cancer Center (Main) — Overland Park, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC — Metairie, Louisiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Maine Center for Cancer Medicine and Blood Disorders — Scarborough, Maine, United States
• Sinai Hospital of Baltimore, Inc. — Baltimore, Maryland, United States
• Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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