Clinical trial NCT01693445: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastrointestinal Neoplasms
Keywords: Gastrointestinal neoplasms
Oxaliplatin
Irinotecan
S-1
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
Collaborators: name: Jeil Pharmaceutical Co., Ltd.
name: HK inno.N Corporation
name: Pfizer
name: Handok Inc.
First posted: 2012-09-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: maximum tolerated dose
timeFrame: 6 months
Secondary outcomes:
measure: toxicity profiles
timeFrame: 6 months
measure: overall response rate
timeFrame: 6 months
measure: progression free survival
timeFrame: 6 months
measure: overall survival
timeFrame: 6 months
measure: disease control rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
Study officials:
affiliation: Hallym University Medical Center
name: Dae Young Zang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: