Colorectal Neoplasms
Conditions
Brief 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.
Interventions
Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
DRUG5-FLUOROURACIL (5-FU)
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
DRUGLEUCOVORIN (LV)
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
DRUGBEVACIZUMAB
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria. | At the end of 8 cycles or end of treatment which occurs first. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | evaluated at 10 weeks, 16 weeks and 40 weeks |
| Duration of response | evaluated at 10 weeks, 16 weeks and 40 weeks |
| Adverse events | At each visit, i.e. every two weeks |
| Overall response rate of stage I and II | evaluated at week 14 |
Countries
Canada
Outcome results
None listed