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Trial Title:
Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
NCT ID:
NCT00506571
Condition:
Colorecal Neoplasms
Secondary
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Oxaliplatin
Irinotecan
Conditions: Keywords:
colorectal neoplasms
secondary
Combination chemotherapy
S-1
irinotecan
oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S-1, irinotecan, oxaliplatin
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Korea
Address:
City:
Goyang
Zip:
410-769
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Kyung Hae Jung, M.D.Ph.D
Phone:
+82-31-920-1611
Email:
khjung@ncc.re.kr
Contact backup:
Last name:
Hwa Jeong Kim
Phone:
+82-31-920-1145
Email:
ncccoloonco@hanmail.net
Investigator:
Last name:
Yong Sang Hong, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Sun Young Kim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hye Suk Han, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Seung-Yong Jeong, M.D.Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Hyo Seong Choi, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Seok-Byung Lim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hee Jin Chang, M.D.Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jun Yong Jeong, M.D.
Email:
Sub-Investigator
Start date:
July 2007
Completion date:
June 2010
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00506571
