drugset / Trial / NCT00856830

Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer

NCT00856830

NaSingle-groupOpen-labelTreatment

Summary

Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.

Timeline

Start
2009-04
Primary completion
2015-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 80 mg/m2 Other
Subject Bendamustine Small molecule 100 mg/m2 Other
Subject Bendamustine Small molecule 120 mg/m2 Other
Subject Irinotecan Small molecule 150 mg/m2 Other
Background Carboplatin Small molecule 6 unknown
Background Etoposide Small molecule 100 mg/m2