Clinical trial NCT00988897: Colorectal Cancer RECHALLENGE
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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.
timeFrame: At the end of 8 cycles or end of treatment which occurs first.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: evaluated at 10 weeks, 16 weeks and 40 weeks
measure: Duration of response
timeFrame: evaluated at 10 weeks, 16 weeks and 40 weeks
measure: Adverse events
timeFrame: At each visit, i.e. every two weeks
measure: Overall response rate of stage I and II
timeFrame: evaluated at week 14
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Medical Affairs
role: STUDY_DIRECTOR
References: