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Trial record 59 of 436 for:    colon cancer AND Capecitabine AND colon cancer

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.
 
ClinicalTrials.gov Identifier: NCT01322152
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
Jin Li, Fudan University

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE March 24, 2011
Last Update Posted Date June 11, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
Rate of Diarrhea [ Time Frame: eight weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
Progression free survival [ Time Frame: eight weeks ]
Change History Complete list of historical versions of study NCT01322152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Rate of diarrhea [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
Official Title  ICMJE Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: irinotecan, capecitabine
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
Study Arms  ICMJE Experimental: wXELIRI regimen
Intervention: Drug: irinotecan, capecitabine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2011)
50
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322152
Other Study ID Numbers  ICMJE XELIRIcrc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Li, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin Li, PhD Fudan University
PRS Account Fudan University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP