Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2009-10-31
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
OXALIPLATIN (SR96669)
Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
5-FLUOROURACIL (5-FU)
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
LEUCOVORIN (LV)
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
BEVACIZUMAB
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OXALIPLATIN (SR96669)
Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
5-FLUOROURACIL (5-FU)
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
LEUCOVORIN (LV)
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
BEVACIZUMAB
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
sanofi-aventis
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Affairs
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
Laval, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OXALI_L_03943
Identifier Type: -
Identifier Source: org_study_id