Colorectal Cancer RECHALLENGE

Sanofi

Status and phase: Withdrawn; Phase 2

Conditions: Colorectal Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988897

OXALI_L_03943

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

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.

Treatment:

Drug: 5-FLUOROURACIL (5-FU)

Drug: LEUCOVORIN (LV)

Drug: BEVACIZUMAB

Drug: OXALIPLATIN (SR96669)