Clinical Trial Protocol Registry

Trial information

A Study of Avastin (Bevacizumab) and FOLFOX in Patients With Colorectal Cancer

Status:
Recruiting
Protocol number:
ML25625
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A multi-center, open-label clinical trial to evaluate the objective response rate of bevacizumab in combination with modified FOLFOX-6 followed by one year of maintenance with bevacizumab alone in patients with initially not or borderline resectable colorectal liver metastases (The CLMO-001 Trial)
Brief summary:
The multi-center, open-label study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with modified FOLFOX6 in patients with colorectal cancer and metastases confined to the liver. Patients will receive Avastin 5mg/kg and mFOLFOX6 (oxaliplatin, folinic acid, 5-fluorouracil) every 2 weeks for 12 cycles. In between these cycles, patients will undergo liver surgery if operable. After the 12 treatment cycles, patients will receive Avastin alone for 52 weeks. Target sample size is 77.
Study phase:
II
Study type:
Interventional; Treatment; Non-randomized; Single group; Safety/efficacy study
Conditions:
  • Colorectal Cancer
Intervention type:
Drug
Intervention name:
bevacizumab [Avastin]
Primary outcome:
  1. Objective response rate Time frame: Up to 11 two-weeks cycles of treatment
Key secondary outcomes:
  1. Percentage of patients undergoing liver resection Time frame: 2 years
  2. Safety: Number of patients with adverse events Time frame: 2 years
  3. Disease-free interval Time frame: 2 years
  4. Progression-free survival Time frame: 2 years
  5. Overall survival Time frame: 2 years
Inclusion criteria:
  • Adult patients, >/=18 years of age
  • Adenocarcinoma of the colon or the rectum
  • Metastatic disease confined to the liver
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • No previous chemotherapy for metastatic disease or treatment with drugs targeting VEGF or EGFR
  • Adequate bone marrow, liver and renal function
Exclusion criteria:
  • Presence of metastases outside of the liver
  • Radiotherapy within 4 weeks before study start
  • History of inflammatory bowel disease
  • Presence of serious non-healing wound or ulcer
  • Uncontrolled hypertension
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
August, 2011
Trial registration date:
31.05.2011
Date last updated:
06.05.2013
This trial is being conducted at the following locations:
Italy
  • ANCONA
  • BOLOGNA
  • CATANIA
  • CHIETI
  • GALLARATE
  • MILANO
  • MODENA
  • NAPOLI
  • PAVIA
  • TORINO
ITALY
  • MILANO

Link to trial result

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