An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of Pemetrexed Prior to Surgery
Feasibility is defined as the ability to receive the total planned dose of pemetrexed (i.e., 1500 mg/m) administered over a period of no more than 9 weeks. Feasibility is measured as absence of the following toxicities: CTC grade 4 lasting >= 7 days, or febrile neutropenia CTC grade 4 thrombocytopenia or grade 3 with bleeding. CTC grade 3 nonhematologic toxicity (excluding nausea and vomiting, isolated CTC grade 3 ALT or AST that returns to the patient's pretreatment CTC grade within 3 weeks, or grade 3 fatigue lasting <7 days).
3 cycles (21-day cycles)
Bengt G Gustavsson, PhD, MD
Sahlgrenska University Hospital, Sweden
Sweden: Medical Products Agency