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A Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer (TIROX2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512681
First Posted: August 8, 2007
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Center, Korea
  Purpose
Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy.

Condition Intervention Phase
Stomach Neoplasms Drug: Irinotecan, Oxaliplatin, TS-1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Maximal overall response rate [ Time Frame: During chemotherapy ]

Secondary Outcome Measures:
  • Progression-free survival,Overall survival,Toxicity assessment,&genetic polymorphism and association with chemical outcomes [ Time Frame: during study period ]

Estimated Enrollment: 44
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Irinotecan, Oxaliplatin, TS-1
    • S-1 40 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
    • Irinotecan 150 mg/m2 mixed in d5w 500 ml iv over 90-min on days 1
    • Oxaliplatin 85 mg/m2 mixed in d5w 250 ml iv over 2-h on days 1
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
  2. Age ≥18 years
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Disease status must be that of measurable disease as defined by RECIST criteria:Measurable lesions: Lesions that can be accurately measured in at least one dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
  5. No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed.
  6. Adequate major organ function including the following: Hematopoietic function: ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl, AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function: serum creatinine UNL
  7. Patients should sign a written informed consent before study entry

Exclusion Criteria:

  1. Prior history of peripheral neuropathy
  2. Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
  3. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  4. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
  5. Psychiatric disorder that would preclude compliance
  6. Pregnant, nursing women or patients with reproductive potential without contraception
  7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512681


Locations
Korea, Republic of
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sook Ryun Park, M.D. National Cancer Center, Korea
  More Information

Responsible Party: Sook Ryun Park, M.D, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00512681     History of Changes
Other Study ID Numbers: NCCCTS-07-264
First Submitted: August 7, 2007
First Posted: August 8, 2007
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by National Cancer Center, Korea:
Stomach Neoplasms
Secondary
Combination chemotherapy
S-1
irinotecan
oxaliplatin

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Irinotecan
Camptothecin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action