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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00512681
First received: August 7, 2007
Last updated: September 17, 2009
Last verified: September 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: August 7, 2007
Last Updated: September 17, 2009
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 29, 2014