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

NCT01693445

Last updated date
Study Location
Hallym University Medical Center
Anyang, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Gastrointestinal NeoplasmsS-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer
NCT01693445
  1. Anyang,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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;

  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
Study Arms  ICMJE 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.
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
 (submitted: August 14, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2012)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:Undecided
Responsible Party Hallym University Medical Center
Study Sponsor  ICMJE Hallym University Medical Center
Collaborators  ICMJE
  • Jeil Pharmaceutical Co., Ltd.
  • HK inno.N Corporation
  • Pfizer
  • Handok Inc.
Investigators  ICMJE
Principal Investigator:Dae Young Zang, MD, PhDHallym University Medical Center
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