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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00506571
Other study ID # NCCCTS-07-261
Secondary ID
Status Recruiting
Phase Phase 2
First received July 23, 2007
Last updated July 23, 2007
Start date July 2007
Est. completion date June 2010

Study information

Verified date April 2007
Source National Cancer Center, Korea
Contact Kyung Hae Jung, M.D.Ph.D
Phone +82-31-920-1611
Email khjung@ncc.re.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date June 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
S-1, irinotecan, oxaliplatin


Locations

Country Name City State
Korea, Republic of National Cancer Center Korea Goyang Gyeonggi

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal overall response rate During chemotherapy
Secondary Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism
See also
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Recruiting NCT00507143 - Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan N/A