NCT01397305

An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Isofol Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an optimal dose of \[6R\] 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	[6R] 5,10-methylenetetrahydrofolate (arfolitixorin)	10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle. 3 cycles.
DRUG	Pemetrexed	500 mg/m2 IV on day 1 of each 21-day cycle. 3 cycles.

Timeline

• Start date: 2011-04-14
• Primary completion: 2014-10-16
• Completion: 2014-10-16
• First posted: 2011-07-19
• Last updated: 2020-09-09

Locations

1 site across 1 country: Sweden