Bevacizumab (BV) plus 5-FU/leucovorin (FU/LV) for advanced colorectal cancer (CRC) that progressed after standard chemotherapies: An NCI Treatment Referral Center trial (TRC-0301).

3515 Background: The addition of bevacizumab (BV, Avastin) to IFL for untreated metastatic CRC produces survival benefit (Hurwitz et al, ASCO 2003), but the role of BV in other CRC settings is not established. The purpose of this trial is to evaluate the combination of BV with FU/LV for patients who have exhausted standard therapeutic options. Methods: This is a single arm, multicenter trial conducted nationwide through TRC. The 1st stage was to obtain the RR in 100 evaluable pts; if efficacy is observed, the 2nd stage would open as an expanded access protocol. Main eligibility criteria: advanced CRC progressing after irinotecan- and oxaliplatin-based regimens, ECOG PS 0–2. Treatment plan: BV 5 mg/kg q 2 wks, plus bolus or infusional FU/LV, in 8-wk cycles. All pts are followed for RR, safety, PFS and OS. Results: Due to rapid accrual, many patients were already in the pipeline awaiting study entry by the time the 1st stage accrual target was met. As a result, 350 pts were enrolled in the 1st stage between...