Clinical trial NCT00506571: Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
Official title: Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorecal Neoplasms
Secondary
Keywords: colorectal neoplasms
secondary
Combination chemotherapy
S-1
irinotecan
oxaliplatin
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2007-07-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximal overall response rate
timeFrame: During chemotherapy
Secondary outcomes:
measure: Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Korea
state: Gyeonggi
Study officials:
affiliation: not affiliated
name: Kyung Hae Jung, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: