- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224652
Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
October 19, 2010 updated by: Korean Cancer Study Group
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
518
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tae-You Kim, M.D., Ph.D.
- Phone Number: 82-2-2072-3943
- Email: kimty@snu.ac.kr
Study Contact Backup
- Name: Jae Yong Cho, M.D., Ph.D.
- Phone Number: 82-2-2019-4363
- Email: chojy@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Principal Investigator:
- Tae-You Kim, M.D., Ph.D.
-
Seoul, Korea, Republic of, 135-720
- Recruiting
- Yonsei University Gangnam Severance Hospital
-
Principal Investigator:
- Jae Yong Cho, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: paclitaxel
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
|
Experimental: irinotecan
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival
Time Frame: every 8 weeks
|
Tumor evaluation using RECIST v1.1
|
every 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 1 year
|
1 year
|
|
Safety
Time Frame: 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
|
up to 4 weeks after last administration of chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Tae-You Kim, M.D., Ph.D., Korean Cancer Stusy Group stomach Cancer Committee
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 14, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Estimate)
October 20, 2010
Last Update Submitted That Met QC Criteria
October 19, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Paclitaxel
- Irinotecan
Other Study ID Numbers
- KCSG-ST10-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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