Review
Copyright ©2013 Baishideng Publishing Group Co.
World J Gastroenterol. Nov 28, 2013; 19(44): 7955-7971
Published online Nov 28, 2013. doi: 10.3748/wjg.v19.i44.7955
Table 2 Current clinical trials considering anti-angiogenic therapies for colorectal cancer
TrialPhaseLineTherapy/armsStatus of trial
BevacizumabNCT01321957II1stFOLFOX + bevacizumab vs FOLFOX + bevacizumab + irinotecanCurrently recruiting participants
NCT00819780II1stPanitumumab + mFOLFOX6 vs bevacizumab + mFOLFOX6Ongoing, but not recruiting participants
NCT01531595II1st3 cycles of XELOX + bevacizumab alternating with 3 cycles of XELIRI + bevacizumabCurrently recruiting participants
NCT01067053II1stBevacizumab + capecitabine + oxaliplatin - 6 cycles; after the first 6 cycles of treatment, continuing only with bevacizumab and capecitabineOngoing, but not recruiting participants
NCT01765582II1stFOLFOXIRI + bevacizumab vs Sequential FOLFOXIRI + bevacizumab vs FOLFOX + bevacizumabCurrently recruiting participants
NCT01006369II-FOLFOX6 + bevacizumab + hydroxychloroquine vs XELOX + bevacizumab + hydroxychloroquineCurrently recruiting participants
NCT01417494II1stChemotherapy (FOLFIRI, FOLFOX, LV5FU2) + bevacizumab vs Chemotherapy (FOLFIRI, FOLFOX, LV5FU2)Currently recruiting participants
NCT01532804II2ndFOLFOX6 + bevacizumab (day 1 = day 15, 12 cycles) vs Raltitrexed + oxaliplatin + bevacizumab ( day 1 = day 21, 8 cycles)Currently recruiting participants
NCT00952029II/III1stFOLFIRI + bevacizumab and during the chemotherapy-free interval maintenance with bevacizumab vs FOLFIRI + bevacizumab and during the chemotherapy-free interval NO maintenanceCurrently recruiting participants
CetuximabNCT01640405III1stmFOLFOX6 + bevacizumab vs FOLFOXIRI + bevacizumabCurrently recruiting participants
NCT00444678II-Cetuximab + capecitabine + oxaliplatinOngoing, but not recruiting participants
NCT01251536II1stCetuximab (standard dose: 250 mg/m2 weekly) vs Cetuximab (dose escalation: days 22 and 29-350 mg/m2, from day 36 onwards - 500 mg/m2 weekly)Currently recruiting participants
NCT01718808II1stCetuximab + capecitabine vs CetuximabCurrently recruiting participants
NCT01867697II1stCetuximab (biweekly) + FOLFIRI (continuously) vs Cetuximab (biweekly) + alternating FOLFIRI and mFOLFOX6Currently recruiting participants
NCT00640081II1stIntermittent chemotherapy plus intermittent cetuximab treatment (12 wk), plus cetuximab followed by a period off all therapy; reintroduction of the same chemotherapy and cetuximab regimen (12 wk after initial progression off treatment) vs Intermittent chemotherapy plus continuous cetuximab treatment (12 wk), plus cetuximab followed by a period of withdrawal of the chemotherapy, but continued weekly cetuximab monotherapy with reintroduction of the same chemotherapy regimen to the cetuximab (12 wk after initial progression off chemotherapy treatment)Ongoing, but not recruiting participants
NCT00479752II1stFOLFOX4 + cetuximab (initial dose: 400 mg/m² in week 1, followed by weekly doses of 250 mg/m²) vs FOLFOX4 + cetuximab (500 mg/m² every 2 wk)Ongoing, but not recruiting participants
NCT00482222III1stOxaliplatin/fluoropyrimidine vs oxaliplatin/fluoropyrimidine + cetuximab pre and post surgeryCurrently recruiting participants
NCT00433927III1stFOLFIRI + cetuximab vs FOLFIRI + bevacizumabOngoing, but not recruiting participants
PanitumumabNCT01228734III1stCetuximab + FOLFOX4 vs FOLFOX4Ongoing, but not recruiting participants
NCT01030042III2ndFOLFOX4 followed, after progression, by irinotecan + cetuximab vs Cetuximab + irinotecanCurrently recruiting participants
NCT00885885II-Panitumumab + FOLFOX4 vs Panitumumab + FOLFOX4Ongoing, but not recruiting participants
NCT01215539II1stPanitumumab + capecitabine + oxaliplatinCurrently recruiting participants
NCT01126112II1stPanitumumab (6 mg/kg every 2 wk )Ongoing, but not recruiting participants
NCT00819780II1stPanitumumab + mFOLFOX 6 vs bevacizumab + mFOLFOX 6Ongoing, but not recruiting participants
NCT01328171II1stFOLFOXIRI + panitumumab vs FOLFOXIRICurrently recruiting participants
NCT01508000II1stmFOLFOX6 (6 cycles after and before surgery) + surgery vs mFOLFOX6 + bevacizumab (6 cycles after and before surgery) + surgery vs mFOLFOX6 + panitumumab (6 cycles after and before surgery) + surgeryNot yet open for participant recruitment
NCT01814501II2nd5-FU + irinotecan + panitumumabCurrently recruiting participants
NCT00940316II2ndErlotinib + panitumumab + irinotecan (treatment repeats every 2 wk) vs Erlotinib + panitumumab (treatment repeats every 2 wk) vs Erlotinib + panitumumabCurrently recruiting participants
NCT00364013III1stFOLFOX + panitumumab vs FOLFOXOngoing, but not recruiting participants
NCT01910610III1stFOLFIRI + cetuximab, followed by oxaliplatin-based chemotherapy + bevacizumab vs OPTIMOX + bevacizumab, followed by irinotecan-based chemotherapy + bevacizumab, followed by an anti-EGFR agent (cetuximab +/- irinotecan or panitumumab) with or without irinotecanNot yet open for participant recruitment
AfliberceptNCT01669720II2ndAflibercept iv (4 mg/kg every 2 wk)Currently recruiting participants
NCT01652196II1stAflibercept iv + mFOLFOX 6 iv (days 1 and 15; repeats every 28 d)Currently recruiting participants
NCT01802684II1stInduction therapy (sequence #1)Regimen: Aflibercept + mFOLFOX7 - 6 cycles (3 mo) Maintenance after induction (sequence #2) First phase (sequence #2A); Regimen: Aflibercept + fluoropyrimidine (simplifed LV5FU2 or capecitabine) - 6 cycles (3 mo) Second phase (sequence #2B); Regimen: Aflibercept +/- fluoropyrimidine (simplifed LV5FU2 or capecitabine) - until PD or limiting toxicity Reintroduction (sequence #3); Regimen: Aflibercept + mFOLFOX7 - 6 cycles (3 mo) Maintenance after reintroduction (sequence #4); Regimen: Aflibercept + fluoropyrimidine - until PD or limiting toxicityNot yet open for participant recruitment
NCT01882868II2ndAflibercept iv + FOLFIRI Aflibercept + FOLFIRI (every 2 wk)Currently recruiting participants
NCT01889680II1stmFOLFOX6 + aflibercept (every 14 d for 6 cycles) plus 5-FU/LV (every 14 d) vs mFOLFOX6 + aflibercept (every 14 d for 6 cycles) plus 5-FU/LV + aflibercept (every 14 d)Not yet open for participant recruitment
NCT01646554II/III1stmFOLFOX6 and SURGERY 6 cycles before and 6 cycles after surgery consisting in: Hour 0: Oxaliplatin 85 mg/m²iv 2-h infusion; Hour 0: Folinic acid 400 mg/m² (DL form) or 200 mg/m2 (L form) iv 2-h infusion; Hour 2: 5-FU 400 mg/m²iv bolus over 2-4 min; Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46 h; On day 1 of a 14 d cycle vs mFOLFOX6 + aflibercept and surgery; 6 cycles before and 6 cycles after surgery consisting in: Hour 0: Aflibercept 4 mg/kg intravenous infusion 1-h; Hour 1: Oxaliplatin 85 mg/m2 2-h infusion; Hour 1: Folinic acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion; Hour 3: 5-FU bolus 400 mg/m2iv bolus over 2-4 min; Hour 3: 5-FU 2400 mg/m² given as a continuous infusion over 46 h; Day 1 of a 14 day cycleNot yet open for participant recruitment
NCT01661270III2ndAflibercept iv (day 1 of each cycle, every 2 wk) + FOLFIRI vs Placebo iv (day 1 of each cycle, every 2 wk) + FOLFIRICurrently recruiting participants
NCT01571284III2ndAflibercept IV (every 2 wk ) + FOLFIRICurrently recruiting participants
NCT01670721III2ndAflibercept IV (on day 1) + FOLFIRI administered as follows: dI-leucovorin infusion over 2 h on day 1; Irinotecan: infusion over 90-min infusion, on day 1, followed by bolus 5-FU and 5-FU continuous infusion over 46 h or as individualized by physician's clinical judgment; Treatment cycle to be administered every 2 wkCurrently recruiting participants
BrivanibNCT01367275II2ndBrivanib (800 mg orally daily days 1-14) + Irinotecan iv (180 mg/m2 on day 1)Ongoing, but not recruiting participants
CediranibNCT00588900II2ndIrinotecan iv (days 1 and 8) + Cediranib oral (days 1-21)The recruitment status of this study is unknown because the information has not been verified recently
RamucirumabNCT01111604II2ndmFOLFOX-6 vs mFOLFOX-6 + ramucirumab ( 8 mg/kg iv infusion, administered every 2 wk) vs mFOLFOX-6 + icrucumab ( 15 mg/kg iv infusion, administered every 2 wk)Ongoing, but not recruiting participants
NCT01183780III2ndFOLFIRI + ramucirumab ( 8 mg/kg administered intravenously every 2 wk) vs FOLFIRI + placeboCurrently recruiting participants
RegorafenibNCT01298570II2ndRegorafenib (160 mg, po, daily, per 7 day cycle) + FOLFIRI (day 1 and day 15 of each 28 d cycle) vs Placebo (oral administration, days 4-10 and days 18-24 of 28 day cycle +)+ FOLFIRI (day 1 and day 15 of each 28 d cycle)Currently recruiting participants
NCT01289821II1stDay 1 and day 15 of each cycle: 85 mg/m² oxaliplatin + folinic acid (either 400 mg/m² D/L-folinic acid or 200 mg/m² L-folinic acid), iv + 400 mg/m² 5 FU iv + 2400 mg/m² 5 iv; Days 4 to 10 and days 18 to 24: regorafenib 160 mg (four 40 mg tablets)Ongoing, but not recruiting participants
NCT01875380II1stRegorafenib (orally, 160 mg per day for 3 wk, followed by 1 wk of rest)Not yet open for participant recruitment
NCT01103323III2ndRegorafenib (160 mg per oral once daily for 3 wk on 1 wk off of every 4 wk cycle) vs Placebo (per oral once daily for 3 wk on 1 wk off of every 4 wk cycle)Ongoing, but not recruiting participants
NCT01584830III2ndRegorafenib [3 wk on/1 wk off (160 mg od po)]Placebo [3 wk on/1 wk off (160 mg od po)]Ongoing, but not recruiting participants
NCT01853319III2ndRegorafenib (160 mg per oral every day for 3 wk of every 4 wk cycle)Not yet open for participant recruitment
NCT01538680III2ndRegorafenib (160 mg po every day for 3 wk on, 1 wk off)Expanded access is currently available for this treatment
SemaxanibNCT00021281III1stSemaxanib iv (on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36 and 39) + irinotecan iv, leucovorin calcium iv, fluorouracil iv (on days 1, 8, 15, and 22) (every 6 wk) vs Irinotecan iv, leucovorin calcium iv, fluorouracil iv (on days 1, 8, 15, and 22) (every 6 wk) vs Semaxanib iv (on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36 and 39) + irinotecan iv (days 1, 15 and 29) + leucovorin calcium iv, fluorouracil iv (on days 1, 2, 15, 16, 29 and 30) vs Irinotecan iv, leucovorin calcium iv, fluorouracil iv (on days 1, 8, 15, and 22) (every 6 wk)The recruitment status of this study is unknown because the information has not been verified recently
SorafenibNCT01715441NEXIRI 2II2ndIrinotecan 180 mg/m2iv with cross over to irinotecan and sorafenib combination at progression vs Sorafenib 400 mg twice daily with cross over to irinotecan and sorafenib combination at progression vs Irinotecan 120 mg/m2iv at cycle 1, 150 mg/m² at cycle 2 and 180 mg/m² at cycle 3 + sorafenib 400 mg twice daily from cycle 1Currently recruiting participants
NCT01471353II2ndSorafenib 200-400 mg po twice daily on days 1-21 (dose escalation scheme) + capecitabine 1000 mg/m2po twice daily on days 1-14 repeated every 21 dCurrently recruiting participants
NCT00826540II2ndSorafenib twice daily on days 1-5 and 8-12 + bevacizumab iv on day 1Ongoing, but not recruiting participants
NCT00839111II2ndSorafenib (400 mg twice daily from day 3 to day 14, day 17-28) + FOLFIRIThe recruitment status of this study is unknown because the information has not been verified recently
NCT01290926II2ndSorafenib (200 mg in the morning, 400 mg in the evening) + capecitabine (850 mg/m2 twice daily)The recruitment status of this study is unknown because the information has not been verified recently
NCT00326495II2ndOral sorafenib (400 mg by twice daily) plus cetuximab (400 mg/m2, week 1; 250 mg/m2iv, weekly)Currently recruiting participants
SunitinibNCT00936832II1stFOLFIRI (on days 1, 15, and 29) + oral sunitinib (on days 1-28). (repeats every 6 wk)The recruitment status of this study is unknown because the information has not been verified recently