Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hokkaido Gastrointestinal Cancer Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209651
First received: September 13, 2005
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: Campto, Topotesin
Drug: TS-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302

Resource links provided by NLM:


Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

Primary Outcome Measures:
  • objective tumor response [ Time Frame: 1-year ]

Secondary Outcome Measures:
  • Response duration, time to progression, overall survival, and safety will also be assessed. [ Time Frame: 2-years ]

Enrollment: 40
Study Start Date: January 2004
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
Irinotecan and S-1
Drug: Campto, Topotesin
q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
Other Name: irinotecan
Drug: TS-1
80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
Other Name: S-1

Detailed Description:

A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological diagnosis of colorectal adenocarcinoma.
  2. Measurable or assessable lesions.
  3. Age: 18 ~ 75 years.
  4. Performance Status (ECOG): 0 ~ 2.
  5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
  6. No history of treatment with CPT-11 or S-1.
  7. No history of radiotherapy to the abdomen.
  8. Oral intake of S-1 is possible.
  9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
  10. Predicted survival for >3 months.
  11. Able to give written informed consent

Exclusion Criteria:

  1. Severe pleural effusion or ascites.
  2. Metastasis to the central nervous system (CNS).
  3. Active gastrointestinal bleeding.
  4. Active infection.
  5. Diarrhea (watery stools).
  6. Uncontrolled ischemic heart disease.
  7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  8. Active multiple cancer.
  9. Severe mental disorder.
  10. Pregnancy, possible pregnancy, or breast-feeding.
  11. Flucytosine treatment
  12. Gilbert's syndrome (4).
  13. Judged to be ineligible for this protocol by the attending physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209651

Locations
Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Investigators
Study Chair: Yoshito Komatsu, MD.PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209651     History of Changes
Other Study ID Numbers: HGCSG0302, IRIS
Study First Received: September 13, 2005
Last Updated: October 31, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
Irinotecan, S-1, Phase II, colorectal cancer,

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

ClinicalTrials.gov processed this record on November 24, 2014