Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00506168
• Other study ID #: NCCCTS-01-024
• Status: Terminated
• Phase: Phase 2
• First received: July 23, 2007
• Last updated: July 23, 2007
• Start date: November 2001
• Est. completion date: July 2007

Study information

• Verified date: July 2007
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Drug Therapy, Combination
• Secondary

Intervention

Drug:
• Irinotecan, Capecitabine

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 response rate and toxicities		During treatment
Secondary	Progression-free survival and overall survival