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Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer (TIROX2)

Primary Purpose

Colorecal Neoplasms, Secondary

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

S-1, irinotecan, oxaliplatin

About this trial

This is an interventional treatment trial for Colorecal Neoplasms focused on measuring colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug

Sites / Locations

National Cancer Center KoreaRecruiting

Outcomes

Primary Outcome Measures

Maximal overall response rate

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00506571

First Posted

July 23, 2007

Last Updated

July 23, 2007

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00506571

Brief Title

Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer

Acronym

TIROX2

Official Title

Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorecal Neoplasms, Secondary

Keywords

colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

S-1, irinotecan, oxaliplatin

Primary Outcome Measure Information:

Title

Maximal overall response rate

Time Frame

During chemotherapy

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kyung Hae Jung, M.D.Ph.D

Phone

+82-31-920-1611

khjung@ncc.re.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Hwa Jung Kim

Phone

+82-31-920-1145

ncccoloonco@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyung Hae Jung, M.D.Ph.D.

Organizational Affiliation

not affiliated

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center Korea

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyung Hae Jung, M.D.Ph.D

Phone

+82-31-920-1611

khjung@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Hwa Jeong Kim

Phone

+82-31-920-1145

ncccoloonco@hanmail.net

First Name & Middle Initial & Last Name & Degree

Yong Sang Hong, M.D.

First Name & Middle Initial & Last Name & Degree

Sun Young Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Hye Suk Han, M.D.

First Name & Middle Initial & Last Name & Degree

Seung-Yong Jeong, M.D.Ph.D

First Name & Middle Initial & Last Name & Degree

Hyo Seong Choi, M.D.

First Name & Middle Initial & Last Name & Degree

Seok-Byung Lim, M.D.

First Name & Middle Initial & Last Name & Degree

Hee Jin Chang, M.D.Ph.D.

First Name & Middle Initial & Last Name & Degree

Jun Yong Jeong, M.D.

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer

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