Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborator: Sanofi
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred

• Unresectable, locally advanced or metastatic

• At least one uni-dimensional measurable lesion by RECIST criteria

• Age 18 to 75 years old

• Estimated life expectancy ≥3 months

• ECOG performance status ≤2

• Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)

• Adequate kidney function (creatinine < 1.5 mg/dL)

• Adequate liver function (bilirubin < 2.0 mg/dL, transaminase levels <2.5 times the upper normal limit)

• Written informed consent

Exclusion Criteria:

• Other tumor type than adenocarcinoma

• Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)

• Presence of CNS metastasis, psychosis, or seizure

• Obvious bowel obstruction

• Evidence of serious gastrointestinal bleeding

• Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• Other serious illness or medical conditions