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

NCT ID: NCT01695772

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-16
• Study Completion Date: 2016-05-12

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Group Type: EXPERIMENTAL

5-FU based doublet chemotherapy

Intervention Type: DRUG

Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.

bevacizumab

Intervention Type: DRUG

5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively

Interventions

5-FU based doublet chemotherapy

Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.

Intervention Type: DRUG

bevacizumab

5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing Cancer Hospital

Beijing, , China

Sun Yet-sen University Cancer Center

Guangzhou, , China

The Second Affiliated Hospital of Zhejiang University College

Hangzhou, , China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, , China

Zhongshan Hospital Fudan University

Shanghai, , China

Liaoning cancer Hospital & Institute

Shenyang, , China

Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

Wuhan, , China

Countries

China

Other Identifiers

ML28419

Identifier Type: -

Identifier Source: org_study_id