A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer

Roche

Status and phase

Completed

Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: 5-FU based doublet chemotherapy

Drug: bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01695772

ML28419

Details and patient eligibility

About

This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult Chinese participants, 18-75 years of age
Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed
Previously untreated unresectable liver-only metastases
Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).
No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, Transarterial chemoembolisation therapy (TACE) and target therapy
Adequate hematological, renal and hepatic function
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Life expectancy greater than (>) 3 months

Exclusion criteria

The relapse has occurred within 6 months of completion of the adjuvant treatment
Expected impossible to achieve complete resection (R0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy
Participant cannot tolerate the surgery
Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
Any extrahepatic metastases and/or recurrence of the primary tumor
Any residual toxicity from previous chemotherapy (except alopecia) of National Cancer Institute Common Toxicity Criteria (NCI CTC) v.4.0 grade 2
Hypertension crisis or encephalopathy
Pregnant or lactating women
Clinically significant cardiovascular disease
Evidence of bleeding diathesis or coagulopathy
Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin
History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)