Colorectal Cancer RECHALLENGE | NCT00988897

NCT00988897

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patients will receive modified FOLFOX-6 regimen: oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.	Drug: OXALIPLATIN (SR96669) Drug: 5-FLUOROURACIL (5-FU) Drug: LEUCOVORIN (LV) Drug: BEVACIZUMAB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OXALIPLATIN (SR96669)	Drug	Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV

Measure	Description	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.

Measure	Description	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

Eligibility Module

Eligibility 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.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site