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

• Status: Completed
• Trial end date: 2016-05-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab

Criteria

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)