Colorectal Cancer RECHALLENGE

NCT00988897 | Withdrawn Phase 2

• 1 other identifier: OXALI_L_03943
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Progression-free survival (PFS)

  evaluated at 10 weeks, 16 weeks and 40 weeks

• Duration of response

  evaluated at 10 weeks, 16 weeks and 40 weeks

• Adverse events

  At each visit, i.e. every two weeks

• Overall response rate of stage I and II

  evaluated at week 14

Study Arms (1)

1

EXPERIMENTAL

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); Drug: LEUCOVORIN (LV); Drug: BEVACIZUMAB

Interventions

OXALIPLATIN (SR96669) DRUG

Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV

1

5-FLUOROURACIL (5-FU) DRUG

Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV

1

LEUCOVORIN (LV) DRUG

Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV

1

BEVACIZUMAB DRUG

Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Laval, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Affairs

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: October 2, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

CA (1)