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

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

April 14, 2011

Primary Completion Date

October 16, 2014

Study Completion Date

October 16, 2014

Conditions

Rectal Cancer

Interventions

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.

Trial Locations (1)

Sahlgrenska University Hospital, Gothenburg