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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of Diarrhea

Outcome Time Frame:

eight weeks

Safety Issue:

Yes

Principal Investigator

Jin Li, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

XELIRIcrc

NCT ID:

NCT01322152

Start Date:

March 2011

Completion Date:

June 2013

Related Keywords:

  • Colorectal Cancer
  • metastases
  • neoplasm
  • Colorectal Neoplasms

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