Maintenance Bevacizumab Only or Bevacizumab Plus Metronomic Chemotherapy in Advanced Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

March 31, 2017

Study Completion Date

September 30, 2017

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Maintenance:BEVACIZUMAB

"Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:~* BEVACIZUMAB 5 mg/kg over 30 minutes, day 1~* IRINOTECAN 165 mg/sqm IV over 1-h, day 1~* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1~* L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1~* 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1~with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):~\- BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks)"

DRUG

Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE

"Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:~* BEVACIZUMAB 5 mg/kg over 30 minutes, day 1~* IRINOTECAN 165 mg/sqm IV over 1-h, day 1~* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1~* L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1~* 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1~with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):~* BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks),~* CAPECITABINE 500 mg/tid orally, continuously,~* CYCLOPHOSPHAMIDE 50 mg/day orally, continuously."

Trial Locations (20)

12100

Azienda Ospedaliera S. Croce E Carle Di Cuneo, Cuneo

16128

E.O. Ospedali Galliera, Genova

20132

Irccs Fondazione Centro S. Raffaele Del Monte Tabor, Milan

25124

Istituto Ospedaliero Fondazione Poliambulanza Di Brescia, Brescia

25125

Pres.Ospedaliero Spedali Civili Brescia, Brescia

26100

Istituti Ospitalieri Di Cremona, Cremona

33100

A.O. Universitaria S. Maria Della Misericordia, Udine

35128

Irccs Istituto Oncologico Veneto (Iov), Padua

37045

Ospedale Per Acuti Mater Salutis Di Legnago, Legnago

42100

Ospedale S. Maria Nuova, Reggio Emilia

44100

A.O. Universitaria Arcispedale S.Anna Di Ferrara, Ferrara

56100

Polo Oncologico Area Vasta Nord Ovest, Pisa

Ausl 5 Di Pisa, Pontedera

59100

Ospedale Mesericordia E Dolce, Prato

80131

A.O. Universitaria Federico Ii Di Napoli, Napoli

03100

Ausl Di Frosinone -, Frosinone

Unknown

Oncologia AUSL 2 Lucca, Lucca

Campus Biomedico, Roma

00186

Ospedale San Giovanni Calibita Fatebenefratelli, Roma

00189

Ospedale San Pietro Fatebenefratelli Di Roma, Roma

All Listed Sponsors
lead

Azienda Ospedaliero, Universitaria Pisana

OTHER

NCT02271464 - Maintenance Bevacizumab Only or Bevacizumab Plus Metronomic Chemotherapy in Advanced Colorectal Cancer | Biotech Hunter | Biotech Hunter