S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will attempt to determine the feasibility of combination of Oxaliplatin, Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborators: CJ HealthCare Corporation; Handok Inc.; Handok Pharmaceuticals Co., Ltd.; HK inno.N Corporation; Jeil Pharmaceutical Co., Ltd.; Pfizer
• Treatments: Camptothecin; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract

• Minimum age of 18 years

• ECOG Performance status 0-2

• Life expectancy >3 months

• Presence of measurable or evaluable disease by RECIST

• Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if more than 4 weeks elapsed since completion of chemotherapy.

• More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)

• Adequate organ functions

• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

• Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant chemotherapy.

• Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.

• Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding

• Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix