Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer

UMIN ID: C000000443

Registered date:04/07/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable advanced/recurrent colorectal cancer
• Date of first enrollment: 2006/05/01
• Target sample size: 42
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest. L-OHP is administered intravenously biweekly(day 1 and 15). On 2nd steps L-OHP is administered with RD intravenously biweekly more than 2 courses. The doses of L-OHP are 70mg/m2 for level 1, 85mg/m2 for level 2, and 55mg/m2 for level 0.

Outcome(s)

• Primary Outcome: Step1:safety;adverse events Step2:Disease control rate
• Secondary Outcome: Step1:Eficacy (response rate(CR+PR),disease control rate, survival Step2: Safety, Response rate, survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) during flucytosine medication 2) Active infection or inflammation 3) Uncontrolled severe Diabtes 4) patient severe medical condition 5) patient with interstitial pneumonitis or the history 6) patient with active gastrointestinal bleeding 7) patient with severe neurotoxicity 8) patient with active chicken pox 9) patient with metastasis of CNS 10) patient with other concurrent malignancy affecting on survival or adverse events 11) pregnant or nursing patient or with intent to bear baby 12) patient with allergic history to drug 13) patient with massive effusion of massive ascites 14) patient evaluated to be inadequate by a attending doctor

Related Information

• Primary Sponsor: Outpatient Oncology Unit Kyoto University Hospital
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology