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• Recruitment Status: Withdrawn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

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Neoplasms	Drug: OXALIPLATIN (SR96669); Drug: 5-FLUOROURACIL (5-FU); Drug: LEUCOVORIN (LV); Drug: BEVACIZUMAB	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: October 2009
• Estimated Primary Completion Date: May 2012
• Estimated Study Completion Date: May 2012

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: At the end of 8 cycles or end of treatment which occurs first. ]

Secondary Outcome Measures :

1. Progression-free survival (PFS) [ Time Frame: evaluated at 10 weeks, 16 weeks and 40 weeks ]
2. Duration of response [ Time Frame: evaluated at 10 weeks, 16 weeks and 40 weeks ]
3. Adverse events [ Time Frame: At each visit, i.e. every two weeks ]
4. Overall response rate of stage I and II [ Time Frame: evaluated at week 14 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada

Sanofi-Aventis Administrative Office

Laval, Canada

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Affairs; Sanofi

More Information

• Responsible Party: Medical Affairs Study Director, sanofi-aventis
• ClinicalTrials.gov Identifier: NCT00988897 History of Changes
• Other Study ID Numbers: OXALI_L_03943
• First Posted: October 2, 2009
• Last Update Posted: December 23, 2009
• Last Verified: December 2009

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Bevacizumab; Oxaliplatin; Fluorouracil; Antineoplastic Agents, Immunological; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Immunosuppressive Agents; Immunologic Factors