Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Completed · Phase 2

Conditions studied: Small Cell Lung Cancer, Carcinoma, Small Cell

In brief

This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Key facts

Study ID

NCT00294190

Run by

SCRI Development Innovations, LLC

People needed

38

Starts

2006-02-01

Expected to finish

2009-07-01

Last updated by the study team

2012-12-10

Who can join

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

You may qualify if…

• Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
• Measurable or evaluable disease
• Able to perform activities of daily living with minimal assistance
• Adequate bone marrow, liver and kidney function
• May have received no more than 3 previous courses of radiation therapy
• Give written informed consent prior to study entry

You may not qualify if…

• Patients with limited stage disease
• History of a prior malignancy within three years
• Female patients who are pregnant or are breast feeding
• Significant history of uncontrolled cardiac disease
• Myocardial infarction or stroke within six months
• Symptomatic peripheral vascular disease
• CNS involvement
• Serious active infection or underlying medical condition

Where it is running

• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Consultants in Blood Disorders and Cancer — Louisville, Kentucky, United States
• Hematology Oncology Life Center — Alexandria, Louisiana, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• Methodist Cancer Center — Omaha, Nebraska, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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