Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Terminated

CT.gov ID

NCT00506168

Collaborator

(none)

Enrollment

Location

67.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Secondary Drug Therapy, Combination	Drug: Irinotecan, Capecitabine	Phase 2

Detailed Description

This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.

Response assessment will be performed every 3 cycles of chemotherapy.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer

Study Start Date :

Nov 1, 2001

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Maximal response rate and toxicities [During treatment]

Secondary Outcome Measures

Progression-free survival and overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed metastatic colorectal cancer
ECOG performance status 0-2
Mesurable lesions
No prior chemotherapyk or radiotherapy for metastatic disease. 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
Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
Adequate organ functions
Expected survival is longer then 6 months
Informed consent

Exclusion Criteria:

Prior systemic chemotherapy for metastatic disease
Prior treatment with oxaliplatin or irinotecan
CNS metastases
Uncontrolled or severe cardiovascular disease
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
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 capecitabine such as flucytosine, phenytoin, or warfarin et al.
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery