S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer

Gastrointestinal Neoplasms Clinical Trial

Official title:

Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693445
• Other study ID #: HMC-HO-GI-1203
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2012
• Last updated: February 18, 2016
• Start date: June 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2012
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Drug:
• OIS (Oxaliplatin, Irinotecan, S-1)
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.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang

Sponsors (5)

Lead Sponsor	Collaborator
Hallym University Medical Center	CJ HealthCare Corporation, Handok Pharmaceuticals Co., Ltd., Jeil Pharmaceutical Co., Ltd., Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose		6 months	No
Secondary	toxicity profiles		6 months	Yes
Secondary	overall response rate		6 months	No
Secondary	progression free survival		6 months	No
Secondary	overall survival		6 months	No
Secondary	disease control rate		6 months	No