Colorectal NeoplasmPhase 1TIROXNCT00506207
A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
A Phase 1 study testing S-1, Irinotecan, Oxaliplatin in people with Colorectal Neoplasm and Gastric Neoplasm, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasm, Gastric Neoplasm, Secondary
- What is being tested?
- S-1, Irinotecan, Oxaliplatin
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease, according to the RECIST criteria or non-measurable disease Measurable lesions
- Previous adjuvant, palliative chemotherapy including 5-FU, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed
- Adequate major organ functions
- Patients should sign a written informed consent before study entry
Who cannot join
- Prior history of peripheral neuropathy
- Inadequate cardiovascular
- Serious concurrent infection or nonmalignant illness
- Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
- Psychiatric disorder 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: A Phase I and Pharmacokinetic Study of S-1 Combined With Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.
Read the detailed description
Dose level and escalating schedule are followings;
- S-1 (level 1/2, 3/4, 5/6: 60, 70, 80 mg/m2/day) every 12-h p.o. on days 1(evening)-15 (morning)
- Irinotecan (level 1,2/3, 4/5, 6: 120, 130, 140, 150 mg/m2) mixed in d5w or normal saline 500 ml iv over 90 min on day 1
- Oxaliplatin 85 mg/m2 fixed dose mixed in d5w 250 ml iv infusion over 2-h on day 1
Treatment will be administered every 3 weeks. Start at dose level 1. Thereafter, dose level 2, 3, 4, 5, and 6. If dose-limiting toxicity (DLT) occurs at dose level 1, dose level at -1 will follow
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose-limiting toxicity (DLT) during treatment cycle 1. At least three patients will be enrolled in each cohort. Before escalating to the next dose level, all three patients should have received at least one treatment cycle. If none of the first three treated patients develops DLT in the first cycle at a specific dose level, dose escalation will be continued. If one of the first three treated patients develops DLT at any dose level, then three additional patients are to be entered on the same dose level. If only one in six patients at a given level experiences a DLT, escalation will proceed. The MTD is defined as the dose level at which at least one-third of patients experienced a DLT. The RD for the subsequent phase II study is defined as the preceding dose level before the MTD is attained. Intra-patient dose escalation will not be permitted. Treatment will be continued in the absence of disease progression or unacceptable toxicity with maximum 12 cycles. For purpose of determining the MTD, only DLT occurring during the first cycle of therapy will be considered.
DLTs are defined as any of following;
- Grade 4 neutropenia lasting at least 7 days or grade 3 or 4 neutropenia associated with fever 38.3C as single axillary temperature or 38 C for 1-h
- Grade 4 thrombocytopenia
- Grade 3 or 4 non-hematological toxicity except alopecia, and nausea/vomiting
- Grade 3 or 4 nausea/vomiting not reduced to grade 1 with aggressive antiemetic support
- Inability of the patient to take 75% of the planned chemotherapy dose during the treatment period
- Conditions
- Colorectal Neoplasm, Gastric Neoplasm, Secondary
- Being tested
- S-1, Irinotecan, Oxaliplatin
- Keywords
- Gastrointestinal neoplasms, Combination chemotherapy, S-1, Irinotecan, Oxaliplatin
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1, Irinotecan, OxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity measured by NCICTC v.3
Measured: During treatment
Blood level of irinotecan and S-1 and their metabolites
Measured: At 1st cycle
Secondary outcomes (1)
Maximal response rate, progression-free survival, survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startSep 2006
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Kyung Hae Jung, M.D.Ph.D, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506207
- Sponsor's protocol ID
- NCCCTS-06-166
- Acronym
- TIROX
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Pharmacokinetic Study of S-1 Combined With Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
- ClinicalTrials.gov ID
- NCT00506207
- Acronym / sponsor ID
- TIROX / NCCCTS-06-166
- Conditions
- Colorectal Neoplasm, Gastric Neoplasm, Secondary
- Keywords
- Gastrointestinal neoplasms, Combination chemotherapy, S-1, Irinotecan, Oxaliplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Sep 2006
- Study completion
- Dec 2009 (estimated)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.
Detailed description
Dose level and escalating schedule are followings;
- S-1 (level 1/2, 3/4, 5/6: 60, 70, 80 mg/m2/day) every 12-h p.o. on days 1(evening)-15 (morning)
- Irinotecan (level 1,2/3, 4/5, 6: 120, 130, 140, 150 mg/m2) mixed in d5w or normal saline 500 ml iv over 90 min on day 1
- Oxaliplatin 85 mg/m2 fixed dose mixed in d5w 250 ml iv infusion over 2-h on day 1
Treatment will be administered every 3 weeks. Start at dose level 1. Thereafter, dose level 2, 3, 4, 5, and 6. If dose-limiting toxicity (DLT) occurs at dose level 1, dose level at -1 will follow
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose-limiting toxicity (DLT) during treatment cycle 1. At least three patients will be enrolled in each cohort. Before escalating to the next dose level, all three patients should have received at least one treatment cycle. If none of the first three treated patients develops DLT in the first cycle at a specific dose level, dose escalation will be continued. If one of the first three treated patients develops DLT at any dose level, then three additional patients are to be entered on the same dose level. If only one in six patients at a given level experiences a DLT, escalation will proceed. The MTD is defined as the dose level at which at least one-third of patients experienced a DLT. The RD for the subsequent phase II study is defined as the preceding dose level before the MTD is attained. Intra-patient dose escalation will not be permitted. Treatment will be continued in the absence of disease progression or unacceptable toxicity with maximum 12 cycles. For purpose of determining the MTD, only DLT occurring during the first cycle of therapy will be considered.
DLTs are defined as any of following;
- Grade 4 neutropenia lasting at least 7 days or grade 3 or 4 neutropenia associated with fever 38.3C as single axillary temperature or 38 C for 1-h
- Grade 4 thrombocytopenia
- Grade 3 or 4 non-hematological toxicity except alopecia, and nausea/vomiting
- Grade 3 or 4 nausea/vomiting not reduced to grade 1 with aggressive antiemetic support
- Inability of the patient to take 75% of the planned chemotherapy dose during the treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease, according to the RECIST criteria or non-measurable disease Measurable lesions
- Previous adjuvant, palliative chemotherapy including 5-FU, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed
- Adequate major organ functions
Key exclusion criteria (7 listed)
- Prior history of peripheral neuropathy
- Inadequate cardiovascular
- Serious concurrent infection or nonmalignant illness
- Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
- Psychiatric disorder that would preclude compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1, Irinotecan, Oxaliplatin | Drug | – |
Primary outcome
Toxicity measured by NCICTC v.3
Time frame: During treatment
Blood level of irinotecan and S-1 and their metabolites
Time frame: At 1st cycle
1 secondary outcome
Maximal response rate, progression-free survival, survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
Related trials for Colorectal Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Hae Jung, M.D.Ph.D principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-1, Irinotecan, Oxaliplatin in people with Colorectal Neoplasm and Gastric Neoplasm, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity measured by NCICTC v.3 (time frame: During treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2007.