Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322152
• Other study ID #: XELIRIcrc
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2011
• Last updated: June 10, 2013
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.

Description:

Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Histologically confirmed colorectal cancer

• Age 18-70 years old

• Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before

• Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• ECOG 0-1

• Life expectancy of more than 3 months.

• Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 100×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, AKP < 4×ULN

Exclusion Criteria:

• Pregnant or lactating patients

• Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety

• Active or uncontrolled infection

• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

• Patients could not swallow the tablets

• Concomitant with brain metastases

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• irinotecan, capecitabine
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Diarrhea		eight weeks	Yes
Secondary	Progression free survival		eight weeks	Yes
Secondary	Response rate		eight weeks	Yes
Secondary	Disease control rate		eight weeks	Yes
Secondary	Overall survival		eight weeks	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		eight weeks	Yes