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Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Colorecal Neoplasms, Secondary

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Trial Information

Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer

Inclusion Criteria:

- Histologically confirmed unresectable or metastatic colorectal cancer, not amenable
to surgery or radiation treatment for curative intent

- At least one unidimensional measurable lesion

- ECOG performance status 0-2.

- No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment
for non-metastatic (M0) disease is allowed if completed at least 6 months prior to
initiation of study treatment

- Adequate major organ functions

- Give written informed consent

Exclusion Criteria:

- Prior systemic chemotherapy for metastatic disease

- Prior treatment with oxaliplatin or irinotecan

- Prior radiotherapy is permitted if it was not administered to target lesions selected
for this study and provided it has been completed at least 4 weeks before

- Prior surgical treatment of stage IV disease is permitted

- CNS metastases

- Prior history of peripheral neuropathy ≥ NCI CTC grade 1

- Uncontrolled or severe cardiovascular disease

- Serious concurrent infection or nonmalignant illness

- Other malignancy within the past 3 years except cured non-melanomatous skin cancer or
carcinoma in situ of the cervix

- Organ allografts requiring immunosuppressive therapy

- Psychiatric disorder or uncontrolled seizure that would preclude compliance

- Pregnant, nursing women or patients with reproductive potential without contraception

- Patients receiving a concomitant treatment with drugs interacting with S-1 such as
flucytosine, phenytoin, or warfarin et al.

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known
dihydropyrimidine dehydrogenase (DPD) deficiency

- Known hypersensitivity to platinum compounds or any of the components of the study

- Major surgery within 3 weeks prior to study treatment starts, or lack of complete
recovery from the effects of major surgery

- Received any investigational drug or agent/procedure, i.e. participation in another
trial within 4 weeks before beginning treatment with study drug

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal overall response rate

Outcome Time Frame:

During chemotherapy

Principal Investigator

Kyung Hae Jung, M.D.Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

not affiliated


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

June 2010

Related Keywords:

  • Colorecal Neoplasms
  • Secondary
  • colorectal neoplasms
  • secondary
  • Combination chemotherapy
  • S-1
  • irinotecan
  • oxaliplatin
  • Neoplasms
  • Colorectal Neoplasms