Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01322152 |
Recruitment Status :
Completed
First Posted : March 24, 2011
Last Update Posted : June 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: irinotecan, capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: wXELIRI regimen |
Drug: irinotecan, capecitabine
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days. |
- Rate of Diarrhea [ Time Frame: eight weeks ]
- Progression free survival [ Time Frame: eight weeks ]
- Response rate [ Time Frame: eight weeks ]
- Disease control rate [ Time Frame: eight weeks ]
- Overall survival [ Time Frame: eight weeks ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: eight weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322152
China, Shanghai | |
Fudan University Shanghai Cancer Center | |
Shanghai, Shanghai, China |
Principal Investigator: | Jin Li, PhD | Fudan University |
Responsible Party: | Jin Li, Dr, Fudan University |
ClinicalTrials.gov Identifier: | NCT01322152 |
Other Study ID Numbers: |
XELIRIcrc |
First Posted: | March 24, 2011 Key Record Dates |
Last Update Posted: | June 11, 2013 |
Last Verified: | June 2013 |
metastases neoplasm |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Capecitabine Irinotecan Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |