Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
- Registration Number
- NCT01224652
- Lead Sponsor
- Korean Cancer Study Group
- Brief Summary
The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 518
Inclusion Criteria
- Histologically confirmed gastric adenocarcinoma in tissue/cell
- 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
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description paclitaxel Paclitaxel Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle irinotecan Irinotecan irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle
- Primary Outcome Measures
Name Time Method progression-free survival every 8 weeks Tumor evaluation using RECIST v1.1
- Secondary Outcome Measures
Name Time Method Safety up to 4 weeks after last administration of chemotherapy Number of Participants and toxicity grade accordong to NCI-CTCAE v3.0 as a Measure of Safety
Overall survival 1 year
Trial Locations
- Locations (2)
Yonsei University Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of