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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

At the end of 8 cycles or end of treatment which occurs first.

Safety Issue:

No

Principal Investigator

Medical Affairs

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Canada: Ethics Review Committee

Study ID:

OXALI_L_03943

NCT ID:

NCT00988897

Start Date:

October 2009

Completion Date:

May 2012

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

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