Colorectal Cancer RECHALLENGE

• Status: Withdrawn
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Bevacizumab; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

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.