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Colorectal Cancer RECHALLENGE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00988897
Recruitment Status : Withdrawn
First Posted : October 2, 2009
Last Update Posted : December 23, 2009
Information provided by:

Tracking Information
First Submitted Date  ICMJE September 28, 2009
First Posted Date  ICMJE October 2, 2009
Last Update Posted Date December 23, 2009
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2009)
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. [ Time Frame: At the end of 8 cycles or end of treatment which occurs first. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00988897 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2009)
  • Progression-free survival (PFS) [ Time Frame: evaluated at 10 weeks, 16 weeks and 40 weeks ]
  • Duration of response [ Time Frame: evaluated at 10 weeks, 16 weeks and 40 weeks ]
  • Adverse events [ Time Frame: At each visit, i.e. every two weeks ]
  • Overall response rate of stage I and II [ Time Frame: evaluated at week 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Colorectal Cancer RECHALLENGE
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: 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
  • Drug: 5-FLUOROURACIL (5-FU)
    Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
    Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
    Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
Study Arms  ICMJE Experimental: 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.

  • Drug: OXALIPLATIN (SR96669)
  • Drug: 5-FLUOROURACIL (5-FU)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 21, 2009)
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2009)
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00988897
Other Study ID Numbers  ICMJE OXALI_L_03943
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Affairs Sanofi
PRS Account Sanofi
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP