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

Secondary Clinical Trial

— TIROX2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00506571
• Other study ID #: NCCCTS-07-261
• 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
• 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

• Colorecal Neoplasms
• Colorectal Neoplasms
• Secondary

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