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Inclusion criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum.
* Metastatic disease that was not amenable to potentially curative treatment.
* Participants with measurable disease.
* One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.
* Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Chiba, Japan
• Chūōku, Japan
• Fukuoka, Japan
• Fukuoka, Japan
• Kashiwa-Shi, Japan
• Kawasaki-Shi, Japan
• Matsuyama, Japan
• Mitaka-Shi, Japan
• Nagoya, Japan
• Osaka, Japan
• Sagamihara-Shi, Japan
• Sapporo, Japan
• Sendai, Japan
• Shimotsuke-Shi, Japan
• Shinjuku-Ku, Japan
• Suita-Shi, Japan
• Sunto-Gun, Japan
• Tsukuba, Japan
• Yufu-Shi, Japan