Overview

This trial is active, not recruiting.

Condition colorectal cancer, neoplasm metastasis
Treatments 5-fu based doublet chemotherapy, bevacizumab [avastin]
Phase phase 4
Target VEGF
Sponsor Hoffmann-La Roche
Start date October 2012
End date April 2016
Trial size 50 participants
Trial identifier NCT01695772, ML28419

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
5-fu based doublet chemotherapy
standard 5-FU based doublet chemotherapy
bevacizumab [avastin]
5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively

Primary Outcomes

Measure
Complete resection rate (R0) in metastatic colorectal cancer patients with previously unresectable liver-only metastases
time frame: approximately 3 years

Secondary Outcomes

Measure
Objective response rate (ORR), tumor assessments according to RECIST v.1.1 criteria
time frame: approximately 3 years
Progression-free survival (PFS) for all patients enrolled in the study
time frame: approximately 3 years
Disease-free survival (DFS) for patients who achieve complete resection
time frame: approximately 3 years
Safety: Incidence of adverse events
time frame: approximately 3 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Adult Chinese patients, 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). Guidelines used to determine unresectability includes: - R0 treatment infeasible with resection - cannot spare two adjacent liver segments - retention of liver volume <30% - vascular flow and biliary drainage cannot be preserved - No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, TACE and target therapy - Adequate hematological, renal and hepatic function - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Life expectancy > 3 months Exclusion Criteria: - The relapse has occurred within 6 months of completion of the adjuvant treatment - Expected impossible to achieve R0 resection and/or gain 30% residual liver volume even with responsive neoadjuvant therapy - Patient 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 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 CNS disease (e-g- primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)

Additional Information

Official title A Multi-center, Single-arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.