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Colorectal Cancer RECHALLENGE

Primary Purpose

Colorectal Neoplasms

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
OXALIPLATIN (SR96669)
5-FLUOROURACIL (5-FU)
LEUCOVORIN (LV)
BEVACIZUMAB
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

Progression-free survival (PFS)
Duration of response
Adverse events
Overall response rate of stage I and II

Full Information

First Posted
September 28, 2009
Last Updated
December 21, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00988897
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Withdrawn
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
OXALIPLATIN (SR96669)
Intervention Description
Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
Intervention Type
Drug
Intervention Name(s)
5-FLUOROURACIL (5-FU)
Intervention Description
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
Intervention Type
Drug
Intervention Name(s)
LEUCOVORIN (LV)
Intervention Description
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
Intervention Type
Drug
Intervention Name(s)
BEVACIZUMAB
Intervention Description
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
evaluated at 10 weeks, 16 weeks and 40 weeks
Title
Duration of response
Time Frame
evaluated at 10 weeks, 16 weeks and 40 weeks
Title
Adverse events
Time Frame
At each visit, i.e. every two weeks
Title
Overall response rate of stage I and II
Time Frame
evaluated at week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Affairs
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada

12. IPD Sharing Statement

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Colorectal Cancer RECHALLENGE

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