A Study of Avastin (Bevacizumab) in Combination With 5-FU Based Doublet Chemotherapy in Patients With Colorectal Cancer And Previously Untreated Unresectable Liver-Only Metastases

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01695772
First received: September 27, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer, Neoplasm Metastasis
Drug: bevacizumab [Avastin]
Drug: 5-FU based doublet chemotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Complete resection rate (R0) in metastatic colorectal cancer patients with previously unresectable liver-only metastases [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR), tumor assessments according to RECIST v.1.1 criteria [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) for all patients enrolled in the study [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS) for patients who achieve complete resection [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver-only metastases Drug: bevacizumab [Avastin]
5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively
Drug: 5-FU based doublet chemotherapy
standard 5-FU based doublet chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695772

Contacts
Contact: Reference Study ID Number: ML28419 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
China
Recruiting
Beijing, China, 100142
Active, not recruiting
Guangzhou, China, 510060
Recruiting
Hangzhou, China, 310009
Recruiting
Harbin, China, 150001
Active, not recruiting
Shanghai, China, 200032
Recruiting
Shenyang, China, 110042
Recruiting
Wuhan, China, 430022
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01695772     History of Changes
Other Study ID Numbers: ML28419
Study First Received: September 27, 2012
Last Updated: April 7, 2014
Health Authority: China: State Food and Drug Administration (SFDA)

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Fluorouracil
Bevacizumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014