Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Korean Cancer Study Group.
Recruitment status was Recruiting
Boryung Pharmaceutical Co., Ltd
Information provided by:
Korean Cancer Study Group
First received: October 14, 2010
Last updated: October 19, 2010
Last verified: October 2010
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
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 150 mg/m2 on Days 1 and 15 of a 28-day cycle
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01224652
|Seoul National University Hospital
|Seoul, Korea, Republic of |
|Principal Investigator: Tae-You Kim, M.D., Ph.D. |
|Yonsei University Gangnam Severance Hospital
|Seoul, Korea, Republic of, 135-720 |
|Principal Investigator: Jae Yong Cho, M.D., Ph.D. |
Korean Cancer Study Group
Boryung Pharmaceutical Co., Ltd
||Tae-You Kim, M.D., Ph.D.
||Korean Cancer Stusy Group stomach Cancer Committee
No publications provided
||Tae-You Kim, Chairperson of Stomach Cancer Committee, Korean Cancer Study Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 14, 2010
||October 19, 2010
||Korea: Ministry for Health, Welfare and Family Affairs
Keywords provided by Korean Cancer Study Group:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Physiological Effects of Drugs
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