Colorectal Cancer RECHALLENGE

• ClinicalTrials.gov Identifier: NCT00988897
• Recruitment Status: Withdrawn
• First Posted: October 2, 2009
• Last Update Posted: December 23, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: September 28, 2009
• First Posted Date: October 2, 2009
• Last Update Posted Date: December 23, 2009
• Study Start Date: October 2009
• Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT00988897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Neoplasms

Intervention

• 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

Study Arms

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.

Interventions:

• Drug: OXALIPLATIN (SR96669)
• Drug: 5-FLUOROURACIL (5-FU)
• Drug: LEUCOVORIN (LV)
• Drug: BEVACIZUMAB

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 21, 2009): 0
• Original Estimated Enrollment (submitted: October 1, 2009): 43
• Estimated Study Completion Date: May 2012
• Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00988897
• Other Study ID Numbers: OXALI_L_03943
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medical Affairs Study Director, sanofi-aventis
• Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: Medical Affairs; Sanofi

• PRS Account: Sanofi
• Verification Date: December 2009