Back to resultsS-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer
Primary Purpose
Gastrointestinal Neoplasms
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OIS (Oxaliplatin, Irinotecan, S-1)
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring Gastrointestinal neoplasms, Oxaliplatin, Irinotecan, S-1
Eligibility Criteria
Inclusion Criteria:
- Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract
- Minimum age of 18 years
- ECOG Performance status 0-2
- Life expectancy >3 months
- Presence of measurable or evaluable disease by RECIST
- Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if more than 4 weeks elapsed since completion of chemotherapy.
- More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)
- Adequate organ functions
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
- Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant chemotherapy.
- Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.
- Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
Sites / Locations
- Hallym University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OIS (Oxaliplatin, Irinotecan, S-1)
Arm Description
Dose level 1 treatment will be delivered as a 2-week cycle as bellows; Oxaliplatin 85 mg/m²IV on day 1 Irinotecan 120 mg/m² IV on day 1 S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.
Outcomes
Primary Outcome Measures
maximum tolerated dose
Secondary Outcome Measures
toxicity profiles
overall response rate
progression free survival
overall survival
disease control rate
Full Information
NCT ID
NCT01693445
First Posted
September 20, 2012
Last Updated
February 18, 2016
Sponsor
Hallym University Medical Center
Collaborators
Jeil Pharmaceutical Co., Ltd., HK inno.N Corporation, Pfizer, Handok Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01693445
Brief Title
S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer
Official Title
Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center
Collaborators
Jeil Pharmaceutical Co., Ltd., HK inno.N Corporation, Pfizer, Handok Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will attempt to determine the feasibility of combination of Oxaliplatin, Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.
Detailed Description
Oxaliplatin or irinotecan has shown a considerable anti-tumor activity, when used in combination with 5-fluorouracil (5-FU) in patients with gastrointestinal (GI) cancer. Oxaliplatin, irinotecan, and 5-FU have different mechanisms of actions and do not share the toxicity profiles. Since they have a synergistic effect, many clinical trials have been conducted recently to evaluate the efficacy of triplet combination consisting of oxaliplatin, irinotecan, and 5-FU, and demonstrated that the triple combination regimen was effective and resulted in survival benefits with favorable toxicity profiles.
S-1 and capecitabine are novel oral fluoropyrimidines and different phase III trials have shown that these oral agents are at least as active and effective as 5-FU with a superior safety profile.
Biweekly triple combination of S-1 with oxaliplatin and irinotecan (OIS) is an interesting alternative to increase convenience and to simply the treatment delivery.
In the present study, we attempt to determine the feasibility of OIS combination, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
Gastrointestinal neoplasms, Oxaliplatin, Irinotecan, S-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OIS (Oxaliplatin, Irinotecan, S-1)
Arm Type
Experimental
Arm Description
Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
Oxaliplatin 85 mg/m²IV on day 1
Irinotecan 120 mg/m² IV on day 1
S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.
Intervention Type
Drug
Intervention Name(s)
OIS (Oxaliplatin, Irinotecan, S-1)
Other Intervention Name(s)
Kabioxaliplatin, Campto, TS-1
Intervention Description
Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
Oxaliplatin 85 mg/m²IV on day 1
Irinotecan 120 mg/m² IV on day 1
S-1 60 mg/m2/day PO on day 1-7
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.
Primary Outcome Measure Information:
Title
maximum tolerated dose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
toxicity profiles
Time Frame
6 months
Title
overall response rate
Time Frame
6 months
Title
progression free survival
Time Frame
6 months
Title
overall survival
Time Frame
6 months
Title
disease control rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract
Minimum age of 18 years
ECOG Performance status 0-2
Life expectancy >3 months
Presence of measurable or evaluable disease by RECIST
Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if more than 4 weeks elapsed since completion of chemotherapy.
More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)
Adequate organ functions
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant chemotherapy.
Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.
Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Young Zang, MD, PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer
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