First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Active, not recruitingOBSERVATIONAL
Enrollment

121

Participants

Timeline

Start Date

November 1, 2017

Primary Completion Date

July 31, 2024

Study Completion Date

December 31, 2024

Conditions
Elderly Metastatic Colorectal Cancer Patients
Interventions
DRUG

Capecitabine

"750 mg/sqm/bid, day 2 to 15; if toxicities grade ≥2 do not occur, pts may subsequently receive capecitabine 1000 mg/sqm/bid, day 2 to 15 starting the second cycle based on investigator's choice.~To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.~If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal."

DRUG

Oxaliplatin

100 mg/sqm iv over 2 hours, day 1 To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.

DRUG

Bevacizumab

"7.5 mg/kg iv over 90 minutes, day 1; if the first infusion is tolerated, then subsequent infusions may be administered in 30 minutes.~If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles."

Trial Locations (1)

35128

Istituto Oncologico Veneto IRCCS, Padua

All Listed Sponsors
lead

Istituto Oncologico Veneto IRCCS

OTHER

NCT03451370 - First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter