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Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

irinotecan, capecitabine

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring metastases, neoplasm

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

wXELIRI regimen

Arm Description

Outcomes

Primary Outcome Measures

Rate of Diarrhea

Secondary Outcome Measures

Progression free survival

Response rate

Disease control rate

Overall survival

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT01322152

First Posted

March 23, 2011

Last Updated

June 10, 2013

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01322152

Brief Title

Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

metastases, neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

wXELIRI regimen

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

irinotecan, capecitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of Diarrhea

Time Frame

eight weeks

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

eight weeks

Title

Response rate

Time Frame

eight weeks

Title

Disease control rate

Time Frame

eight weeks

Title

Overall survival

Time Frame

eight weeks

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Li, PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25527007

Citation

Li W, Xu J, Shen L, Liu T, Guo W, Zhang W, Chen Z, Zhu X, Li J. Phase II study of weekly irinotecan and capecitabine treatment in metastatic colorectal cancer patients. BMC Cancer. 2014 Dec 19;14:986. doi: 10.1186/1471-2407-14-986.

Results Reference

derived

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Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

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