Colorectal Cancer RECHALLENGE

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00988897
• Other study ID #: OXALI_L_03943
• Status: Withdrawn
• Phase: Phase 2
• First received: September 28, 2009
• Last updated: December 21, 2009
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• 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
• 5-FLUOROURACIL (5-FU)
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
• LEUCOVORIN (LV)
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
• BEVACIZUMAB
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At the end of 8 cycles or end of treatment which occurs first.	No
Secondary	Progression-free survival (PFS)		evaluated at 10 weeks, 16 weeks and 40 weeks	No
Secondary	Duration of response		evaluated at 10 weeks, 16 weeks and 40 weeks	No
Secondary	Adverse events		At each visit, i.e. every two weeks	No
Secondary	Overall response rate of stage I and II		evaluated at week 14