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

This study is currently recruiting participants.
Verified September 2012 by Hallym University Medical Center
Sponsor:
Collaborators:
Jeil Pharmaceutical Co., Ltd.
CJ Cheiljedang Corporation
Pfizer
Handok Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01693445
First received: September 20, 2012
Last updated: September 22, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Neoplasms
Drug: OIS (Oxaliplatin, Irinotecan, S-1)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity profiles [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • disease control rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OIS (Oxaliplatin, Irinotecan, S-1)

Dose level 1 treatment will be delivered as a 2-week cycle as bellows;

  1. Oxaliplatin 85 mg/m²IV on day 1
  2. Irinotecan 120 mg/m² IV on day 1
  3. 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.
Drug: OIS (Oxaliplatin, Irinotecan, S-1)

Dose level 1 treatment will be delivered as a 2-week cycle as bellows;

  1. Oxaliplatin 85 mg/m²IV on day 1
  2. Irinotecan 120 mg/m² IV on day 1
  3. 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.

Other Names:
  • Kabioxaliplatin
  • Campto
  • TS-1

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693445

Contacts
Contact: Dae Young Zang, MD, PhD 82313803871 fhdzang@hallym.or.kr
Contact: Yuri Lee, RN 82313803704 leeyuri0302@naver.com

Locations
Korea, Republic of
Hallym University Medical Center Recruiting
Anyang, Korea, Republic of
Contact: Dae Young Zang, MD, PhD    82313803871    fhdzang@hallym.or.kr   
Contact: Yuri Lee, RN    82313803704    leeyuri0302@naver.com   
Sub-Investigator: Hyeong Su Kim, MD         
Sub-Investigator: Boram Han, MD         
Sponsors and Collaborators
Hallym University Medical Center
Jeil Pharmaceutical Co., Ltd.
CJ Cheiljedang Corporation
Pfizer
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Dae Young Zang, MD, PhD Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01693445     History of Changes
Other Study ID Numbers: HMC-HO-GI-1203
Study First Received: September 20, 2012
Last Updated: September 22, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hallym University Medical Center:
Gastrointestinal neoplasms
Oxaliplatin
Irinotecan
S-1

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

ClinicalTrials.gov processed this record on April 15, 2014