Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
NCT ID: NCT01224652
Last Updated: 2010-10-20
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
PHASE3
518 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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paclitaxel
Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
Paclitaxel
Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
irinotecan
irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle
Irinotecan
irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle
Interventions
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Paclitaxel
Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
Irinotecan
irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle
Eligibility Criteria
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Inclusion Criteria
* Recurrent or metastatic gastric cancer that has progressed following first- line therapy
* Patients must be ≥18 years of age.
* ECOG performance status ≤ 2
* At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
* Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin ≥ 9.0 g/dL White blood cells (WBC) ≥ 3000/µL Absolute neutrophil count (ANC) ≥ 1500/µL Platelet count ≥ 100 x 103/µL Total bilirubin ≤ 1.5 x upper normal limit (UNL) Creatinine clearance ≥ 60 ml/min or Serum creatinine ≤ 1.5 x UNL AST (SGOT)/ALT (SGPT) ≤ 2.5 x UNL unless liver metastases are present in which case it must be ≤ 5x UNL
* Life expectancy ≥ 12 weeks.
* Written informed consent
* Provision of informed consent for genetic research (In case of optional genetic research)
Exclusion Criteria
* Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
* Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
* Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
* Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
* Ongoing toxicities (\>CTCAE grade 2) caused by previous cancer therapy.
* Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
* Medically uncontrolled, clinically significant heart disease or infection
* Patients with symptomatic uncontrolled brain metastases.
* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
* Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.
* Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment
18 Years
ALL
No
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Korean Cancer Study Group
OTHER
Responsible Party
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Korean Cancer Study Group
Principal Investigators
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Tae-You Kim, M.D., Ph.D.
Role: STUDY_CHAIR
Korean Cancer Stusy Group stomach Cancer Committee
Locations
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Yonsei University Gangnam Severance Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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References
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Lee KW, Maeng CH, Kim TY, Zang DY, Kim YH, Hwang IG, Oh SC, Chung JS, Song HS, Kim JW, Jeong SJ, Cho JY. A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01). Oncologist. 2019 Jan;24(1):18-e24. doi: 10.1634/theoncologist.2018-0142. Epub 2018 Aug 20.
Other Identifiers
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KCSG-ST10-01
Identifier Type: -
Identifier Source: org_study_id