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

Status

Unknown

Conditions

Intervention / Treatment

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 Locations

  • Korea, Republic of
      • 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
Drug: 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
Experimental: irinotecan
irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle
Drug: 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

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

Korean Cancer Study Group

Collaborators

Boryung Pharmaceutical Co., Ltd

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.

General Publications

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

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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