A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer

PHASE4CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

June 26, 2012

Primary Completion Date

September 15, 2016

Study Completion Date

September 30, 2016

Conditions
Colorectal Neoplasms
Interventions
DRUG

Oxaliplatin

Participants will receive oxaliplatin 85 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of every 2 weeks cycle during alternative Phase A treatment or 130 mg/m\^2 on Day 1 of every 3 weeks cycle during Phase A treatment.

DRUG

Capecitabine

Participants will receive capecitabine 1000 mg/m\^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle during Phase A treatment.

DRUG

Bevacizumab

Participants will receive 7.5 mg/kg IV infusion on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).

DRUG

Leucovorin

Participants will receive leucovorin 400 mg/m\^2 IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B). Investigators may elect to chose low dose of leucovorin (either 20 mg/m\^2 or 50 mg total dose).

DRUG

5-Fluouracil

Participants will receive 5-fluouracil loading dose of 400 mg/m\^2 IV on Day 1 followed by 2400 mg/m\^2 continuous IV infusion over 46 hours Day 1 (Alternative Phase A treatment and Phase B).

DRUG

Irinotecan

Participants will receive irinotecan 180 mg/m\^2 IV on Day 1 every 2 weeks during Phase B treatment.

Trial Locations (17)

2010

St Vincent'S Hospital; Clinical Oncology, Darlinghurst

2050

Chris O'Brien Lifehouse, Camperdown

2065

Royal North Shore Hospital; Department of Medical Oncology, St Leonards

2076

Sydney Adventist Hospital; Clinical Trial Unit, Sydney

2444

Mid North Coast Cancer Institute, Port Macquarie

2560

Macarthur Cancer Therapy Centre, Campbelltown

2605

Canberra Hospital, Garran

3084

Austin Hospital; Medical Oncology, Heidelberg

4029

Royal Brisbane Hospital, Brisbane

4700

Rockhampton Hospital, Rockhampton

4812

The Townsville Hospital; Townsville Cancer Centre, Townsville

5006

Calvary North Adelaide; North Adeliade Oncology Centre, North Adelaide

5112

Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit, Elizabeth Vale

6008

St John of God Hospital; Bendat Cancer Centre, Subiaco

6150

St John of God Murdoch Hospital; Oncology West, Murdoch

7250

Launceston General Hospital, Launceston

Unknown

Sunshine Hospital; Oncology Research, St Albans

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01588990 - A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter