NCT00291785

Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer

Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CT-2106	CT-2106 as 10 minute infusion on days 1, 15 \& 29 of each 42-day cycle
DRUG	Folinic acid	Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
DRUG	5-FU (fluorouracil)	5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30.

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-08-01
• Completion: 2008-09-01
• First posted: 2006-02-15
• Last updated: 2011-06-08

Locations

2 sites across 1 country: Italy