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
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by:
Korean Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01224652
First received: October 14, 2010
Last updated: October 19, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Paclitaxel
Drug: Irinotecan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Korean Cancer Study Group:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
    Tumor evaluation using RECIST v1.1


Secondary Outcome Measures:
  • Safety [ Time Frame: up to 4 weeks after last administration of chemotherapy ] [ Designated as safety issue: Yes ]
    Number of Participants and toxicity grade accordong to NCI-CTCAE v3.0 as a Measure of Safety

  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 518
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224652

Contacts
Contact: Tae-You Kim, M.D., Ph.D. 82-2-2072-3943 kimty@snu.ac.kr
Contact: Jae Yong Cho, M.D., Ph.D. 82-2-2019-4363 chojy@yuhs.ac

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Tae-You Kim, M.D., Ph.D.         
Yonsei University Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Principal Investigator: Jae Yong Cho, M.D., Ph.D.         
Sponsors and Collaborators
Korean Cancer Study Group
Boryung Pharmaceutical Co., Ltd
Investigators
Study Chair: Tae-You Kim, M.D., Ph.D. Korean Cancer Stusy Group stomach Cancer Committee
  More Information

No publications provided

Responsible Party: Tae-You Kim, Chairperson of Stomach Cancer Committee, Korean Cancer Study Group
ClinicalTrials.gov Identifier: NCT01224652     History of Changes
Other Study ID Numbers: KCSG-ST10-01
Study First Received: October 14, 2010
Last Updated: October 19, 2010
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Korean Cancer Study Group:
gastric cancer
paclitaxel
irinotecan

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014