Colorectal Cancer RECHALLENGE

A Phase II Study of Modified FOLFOX-6 Chemotherapy as First-line Treatment of Metastatic Colorectal Cancer in Patients Who Have Received Oxaliplatin-based Adjuvant Chemotherapy

Primary Objective:

• To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.

Secondary Objective:

• To evaluate other measures of tumour's responses and safety.

Inclusion criteria:

• Histologically proven adenocarcinoma of colon or rectum

• Measurable metastatic disease, either inoperable, or residual after surgical procedure

• No prior chemotherapy for metastatic disease

• For colon cancer: prior adjuvant chemotherapy with oxaliplatin that ended at least 12 months prior to enrollment.

• For rectal cancer: at least 12 months since prior use of oxaliplatin in neoadjuvant or adjuvant chemotherapy

• Adequate liver and kidney function:

  • Total bilirubin inferior to 1.5 ULN
  • Serum Creatinine inferior to 150 umol/L
  • Creatinine clearance (ClCr) > 30 mL/min
  • ALT / AST inferior to 3 ULN

• Adequate hematological function

  • Neutrophils > or equal 1.5 x 109/L
  • Platelets > or equal 100 x 109/L

Exclusion criteria:

• Metastatic disease presenting without prior adjuvant chemotherapy
• Metastatic disease presenting after non-oxaliplatin-containing adjuvant chemotherapy
• Peripheral sensory or motor neuropathy > grade 1
• Eastern Cooperative Oncology Group (ECOG) Performance status > 2
• Other active malignancy
• History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to Leucovorin or to any ingredients in the formulations or the containers
• Patients who are pregnant, or breast-feeding
• Patients with severe renal impairment (ClCr < 30 mL/min)
• Pernicious anemia or other megaloblastic anemia with Vitamin B12 deficiency
• Patients with reproductive potential not implementing accepted and effective method of contraception (the definition of effective method of contraception will be based on the investigators' judgment)
• Participation in another clinical trial with any investigational drug within 30 days prior to study screening
• For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with know hypersensitivity to any components of the product and to Chinese hamster ovary cell product or other recombinant human or humanized antibodies
• Presence of any symptoms suggesting brain metastasis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.