NCT00695292

Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer

Phase II Study of Irinotecan, Carboplatin, and Sunitinib in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This proposed Phase II trial will investigate the combination of irinotecan and carboplatin followed by sunitinib in the first-line treatment of patients with extensive-stage SCLC.

Detailed description

Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. The irinotecan/carboplatin doses that will be used in this study have been used in two previous Phase II SCLC trials, and were found to be extremely well tolerated (Thompson et al. 2005; Spigel et al. 2007). Adding a novel, minimally toxic agent to this regimen may further enhance efficacy in this patient population without contributing to toxicity. This trial will evaluate the use of sunitinib following 6 cycles of treatment with chemotherapy in the treatment of SCLC. The trial will be performed under the leadership of SCRI, a community-based, multi-center, clinical trial organization.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	irinotecan	irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
DRUG	Carboplatin	carboplatin AUC=4 on Day 1
DRUG	sunitinib	sunitinib 25 mg orally (PO) daily after initial chemotherapy

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-06-01
• Completion: 2012-09-01
• First posted: 2008-06-11
• Last updated: 2021-11-22
• Results posted: 2013-02-15

Locations

10 sites across 1 country: United States