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)

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