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Colorectal Cancer RECHALLENGE

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00988897
First received: September 28, 2009
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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.

Condition Intervention Phase
Colorectal Neoplasms
 Drug: OXALIPLATIN (SR96669)
Drug: 5-FLUOROURACIL (5-FU)
Drug: LEUCOVORIN (LV)
Drug: BEVACIZUMAB
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: evaluated at 10 weeks, 16 weeks and 40 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: evaluated at 10 weeks, 16 weeks and 40 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At each visit, i.e. every two weeks ] [ Designated as safety issue: No ]
  • Overall response rate of stage I and II [ Time Frame: evaluated at week 14 ]

Enrollment: 0
Study Start Date: October 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Drug: LEUCOVORIN (LV)
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
Drug: BEVACIZUMAB
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988897

Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Affairs Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00988897     History of Changes
Other Study ID Numbers: OXALI_L_03943
Study First Received: September 28, 2009
Last Updated: December 21, 2009
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Bevacizumab
Leucovorin
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on June 18, 2013