A Study of TS-1 Plus Irinotecan and Cisplatin (IP) for Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00874328
Last Updated: 2010-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
74 participants
INTERVENTIONAL
2008-10-31
2012-12-31
Brief Summary
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TS-1 (Jeil Pharmaceutical Co.,Ltd, Seoul, Korea) is an oral anticancer drug comprised of tegafur, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, in a molar ratio of 1:0.4:1. Tegafur is a prodrug that generates 5-fluorouracil (5-FU) in blood via metabolism by liver enzyme, and 5-chloro-2, 4-dihydroxypyridine enhance the serum concentration of 5-FU by the competitive inhibition of dihydropyrimidine dehydrogenase, an enzyme responsible for 5-FU catabolism. Potassium oxonate is also a reversible competitive inhibitor of orotate phosphoribosyl transferase, a phosphoenzyme for 5-FU. Diarrhea induced by 5-FU administration is though to be attributable to the phosphorylation of 5-FU by the enzyme in the gastrointestinal tissue. After oral administration of potassium oxonate, the concentration of potassium in the gastrointestinal tissue is high enough to inhibit the enzyme while the concentration in blood and tumor is reported to be either slight or nil. Because of these mechanism, oral TS-1 administration generates a higher concentration of 5-FU than protracted intravenous infusion of 5-FU given in a dose equimolar to the tegafur in S-1, whereas the incidence of adverse events concerning the GI tract does not increase. In a phase II trial of TS-1 as first-line setting in NSCLC, the response rate was 22% and the median survival time was 10.2 months. As expected, the incidence of severe gastrointestinal adverse events was low, and so was few severe hematologic toxicity. Recently 3-weekly TS-1 plus cisplatin showed activity against NSCLC with a response rate of 32.7% and the safety was acceptable.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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study arm
Irinotecan /IV D1 Cisplatin 60mg/m2 iv D1 S-1 bid, P.o. D1 \~ 14 q 3 weeks until maximum 6 cycles
Irinotecan
Irinotecan iv D1 q 3 weeks until maximum 6 cycles
Cisplatin
cisplatin 60mg/m2 iv D1 q 3weeks until maximum 6 cycles
TS-1 (S-1)
TS-1 po D1\~D14 q 3 weeks until maximum 6 cycles
Interventions
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Irinotecan
Irinotecan iv D1 q 3 weeks until maximum 6 cycles
Cisplatin
cisplatin 60mg/m2 iv D1 q 3weeks until maximum 6 cycles
TS-1 (S-1)
TS-1 po D1\~D14 q 3 weeks until maximum 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. In phase I, previous chemotherapy including cytotoxic chemotherapy except for irinotecan and cisplatin therapy, targeted therapy and/or radiotherapy is allowed; patients are required to have discontinued previous anti-tumor treatment for at least 4 weeks. Neoadjuvant chemotherapy or adjuvant chemotherapy is allowed and regarded as one-time systemic chemotherapy.
3. In phase II, no prior chemotherapy, radiotherapy or target therapy is allowed. (Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. Neoadjuvant chemotherapy or adjuvant chemotherapy is not allowed.)
4. Performance status of 0, 1, 2 on the ECOG criteria.
5. At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST 2000).
6. Estimated life expectancy of at least 12 weeks.
7. Patient compliance that allows adequate follow-up.
8. Adequate organ function.
9. Metastasis of CNS is not regard to exclusion if the symptom is controlled properly for supportive care including corticosteroid.
10. Informed consent from patient
11. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study treatment.
Exclusion Criteria
2. Serious concomitant infection including post-obstructive pneumonia
3. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years from the diagnosis without recurrence)
4. Pregnant or nursing women
5. Psychiatric disorder that would preclude compliance.
6. Major surgery other than biopsy within the past two weeks.
7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
18 Years
ALL
No
Sponsors
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Jeil Pharmaceutical Co., Ltd.
INDUSTRY
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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National Cancer Center, Korea
Principal Investigators
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Heung Tae Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCCCTS-08-333
Identifier Type: -
Identifier Source: org_study_id