NCT00506571

Brief Summary

Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.

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
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

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

July 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 25, 2007

Status Verified

April 1, 2007

First QC Date

July 23, 2007

Last Update Submit

July 23, 2007

Conditions

Colorecal NeoplasmsSecondary

Keywords

colorectal neoplasmssecondaryCombination chemotherapyS-1irinotecanoxaliplatin

Outcome Measures

Primary Outcomes (1)

  • Maximal overall response rate

    During chemotherapy

Secondary Outcomes (1)

  • Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism

Interventions

S-1, irinotecan, oxaliplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent
  • At least one unidimensional measurable lesion
  • ECOG performance status 0-2.
  • No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment
  • Adequate major organ functions
  • Give written informed consent

You may not qualify if:

  • Prior systemic chemotherapy for metastatic disease
  • Prior treatment with oxaliplatin or irinotecan
  • Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
  • Prior surgical treatment of stage IV disease is permitted
  • CNS metastases
  • Prior history of peripheral neuropathy ≥ NCI CTC grade 1
  • Uncontrolled or severe cardiovascular disease
  • Serious concurrent infection or nonmalignant illness
  • Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
  • Organ allografts requiring immunosuppressive therapy
  • Psychiatric disorder or uncontrolled seizure that would preclude compliance
  • Pregnant, nursing women or patients with reproductive potential without contraception
  • Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Known hypersensitivity to platinum compounds or any of the components of the study medications
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasm MetastasisColorectal Neoplasms

Interventions

S 1 (combination)IrinotecanOxaliplatin

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Kyung Hae Jung, M.D.Ph.D.

    not affiliated

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hae Jung, M.D.Ph.D

CONTACT

+82-31-920-1611khjung@ncc.re.kr

Hwa Jung Kim

CONTACT

+82-31-920-1145ncccoloonco@hanmail.net

Study Design

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

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 25, 2007

Study Start

July 1, 2007

Study Completion

June 1, 2010

Last Updated

July 25, 2007

Record last verified: 2007-04

Locations

KR(1)