S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer
NCT01693445
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer | |||
| Official Title ICMJE | Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Gastrointestinal Neoplasms | |||
| Intervention ICMJE | Drug: OIS (Oxaliplatin, Irinotecan, S-1)
Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
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. Other Names:
| |||
| Study Arms ICMJE | Experimental: OIS (Oxaliplatin, Irinotecan, S-1)
Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
Intervention: Drug: OIS (Oxaliplatin, Irinotecan, S-1) | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 22 | |||
| Original Estimated Enrollment ICMJE | 30 | |||
| Actual Study Completion Date ICMJE | August 2014 | |||
| Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01693445 | |||
| Other Study ID Numbers ICMJE | HMC-HO-GI-1203 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE |
| |||
| Responsible Party | Hallym University Medical Center | |||
| Study Sponsor ICMJE | Hallym University Medical Center | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Hallym University Medical Center | |||
| Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||