Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer (TIROX2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506571
Recruitment Status : Unknown
Verified April 2007 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
Information provided by:
National Cancer Center, Korea

Brief Summary:
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.

Condition or disease Intervention/treatment Phase
Colorecal Neoplasms Secondary Drug: S-1, irinotecan, oxaliplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
Study Start Date : July 2007
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Maximal overall response rate [ Time Frame: During chemotherapy ]

Secondary Outcome Measures :
  1. Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 registration
  • 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 medications
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00506571

Contact: Kyung Hae Jung, M.D.Ph.D +82-31-920-1611
Contact: Hwa Jung Kim +82-31-920-1145

Korea, Republic of
National Cancer Center Korea Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Kyung Hae Jung, M.D.Ph.D    +82-31-920-1611   
Contact: Hwa Jeong Kim    +82-31-920-1145   
Sub-Investigator: Yong Sang Hong, M.D.         
Sub-Investigator: Sun Young Kim, M.D.         
Sub-Investigator: Hye Suk Han, M.D.         
Sub-Investigator: Seung-Yong Jeong, M.D.Ph.D         
Sub-Investigator: Hyo Seong Choi, M.D.         
Sub-Investigator: Seok-Byung Lim, M.D.         
Sub-Investigator: Hee Jin Chang, M.D.Ph.D.         
Sub-Investigator: Jun Yong Jeong, M.D.         
Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Kyung Hae Jung, M.D.Ph.D. not affiliated Identifier: NCT00506571     History of Changes
Other Study ID Numbers: NCCCTS-07-261
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: April 2007

Keywords provided by National Cancer Center, Korea:
colorectal neoplasms
Combination chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action