Inclusion Criteria

Inclusion criteria:

Histologically or cytologically proven adenocarcinoma of the colon or rectum. Metastatic
disease that is not amenable to potentially curative treatment. Patients with measurable
disease. One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic
disease. Patient who relapsed within 6 months of completion of oxaliplatin-based adjuvant
chemotherapy are also eligible.

Exclusion criteria:

Prior therapy with irinotecan. Less than 28 days elapsed from prior radiotherapy, prior
surgery, or prior chemotherapy to the time of registration.

Unresolved toxicity (grade >1) from prior anticancer therapy. Eastern Cooperative Oncology
Group (ECOG) performance status >1. Brain metastases, uncontrolled spinal cord
compression, or carcinomatous meningitis.

Other prior malignancy. Pregnant or breast-feeding women. Uncontrolled hypertension.
Inadequate bone marrow function, liver function, or renal function.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.