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Trial record 1 of 1 for:    NCT01322152
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Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01322152
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : June 11, 2013
Information provided by (Responsible Party):
Jin Li, Fudan University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: irinotecan, capecitabine Phase 2

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.

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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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Rate of Diarrhea [ Time Frame: eight weeks ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: eight weeks ]
  2. Response rate [ Time Frame: eight weeks ]
  3. Disease control rate [ Time Frame: eight weeks ]
  4. Overall survival [ Time Frame: eight weeks ]
  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: eight weeks ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01322152

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China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Sponsors and Collaborators
Fudan University
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Principal Investigator: Jin Li, PhD Fudan University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jin Li, Dr, Fudan University 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
Keywords provided by Jin Li, Fudan University:
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors