NCT00209651

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Jan 2004

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

October 31, 2007

Conditions

Colorectal Cancer

Keywords

Irinotecan, S-1, Phase II, colorectal cancer,

Outcome Measures

Primary Outcomes (1)

  • objective tumor response

    1-year

Secondary Outcomes (1)

  • Response duration, time to progression, overall survival, and safety will also be assessed.

    2-years

Study Arms (1)

1

EXPERIMENTAL

Irinotecan and S-1

Drug: Campto, TopotesinDrug: TS-1

Interventions

Campto, TopotesinDRUG

q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.

Also known as: irinotecan
1
TS-1DRUG

80 mg/m2, PO (oral) on day 1\~14 of each 28 day cycle.

Also known as: S-1
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of colorectal adenocarcinoma.
  • Measurable or assessable lesions.
  • Age: 18 \~ 75 years.
  • Performance Status (ECOG): 0 \~ 2.
  • 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.
  • No history of treatment with CPT-11 or S-1.
  • No history of radiotherapy to the abdomen.
  • Oral intake of S-1 is possible.
  • 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).
  • Predicted survival for \>3 months.
  • Able to give written informed consent

You may not qualify if:

  • Severe pleural effusion or ascites.
  • Metastasis to the central nervous system (CNS).
  • Active gastrointestinal bleeding.
  • Active infection.
  • Diarrhea (watery stools).
  • Uncontrolled ischemic heart disease.
  • Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  • Active multiple cancer.
  • Severe mental disorder.
  • Pregnancy, possible pregnancy, or breast-feeding.
  • Flucytosine treatment
  • Gilbert's syndrome (4).
  • Judged to be ineligible for this protocol by the attending physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecantitanium silicideS 1 (combination)

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Yoshito Komatsu, MD.PhD

    Hokkaido Gastrointestinal Cancer Study Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2004

Study Completion

December 1, 2007

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

JP(1)