NCT00311610

Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer.

Detailed description

OBJECTIVES: Primary * Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer. Secondary * Determine the toxicity profile of this drug in these patients. * Determine the proportion of patients treated with this drug who experience any grade 3 or greater toxicity. * Determine progression-free survival and overall survival for patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 3 years.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SN-38 liposome	38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-01-01
• Completion: 2010-06-01
• First posted: 2006-04-06
• Last updated: 2016-06-29

Locations

10 sites across 1 country: United States