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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00506571
First received: July 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention Phase
Colorecal Neoplasms
Secondary
Drug: S-1, irinotecan, oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

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

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

Estimated Enrollment: 42
Study Start Date: July 2007
Estimated Study Completion Date: June 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506571

Contacts
Contact: Kyung Hae Jung, M.D.Ph.D +82-31-920-1611 khjung@ncc.re.kr
Contact: Hwa Jung Kim +82-31-920-1145 ncccoloonco@hanmail.net

Locations
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    khjung@ncc.re.kr   
Contact: Hwa Jeong Kim    +82-31-920-1145    ncccoloonco@hanmail.net   
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
Investigators
Principal Investigator: Kyung Hae Jung, M.D.Ph.D. not affiliated
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00506571     History of Changes
Other Study ID Numbers: NCCCTS-07-261
Study First Received: July 23, 2007
Last Updated: July 23, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
colorectal neoplasms
secondary
Combination chemotherapy
S-1
irinotecan
oxaliplatin

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Oxaliplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014