Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin Li, Fudan University
ClinicalTrials.gov Identifier:
NCT01322152
First received: March 23, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: irinotecan, capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Rate of Diarrhea [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
  • Disease control rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322152

Locations
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, PhD Fudan University
  More Information

No publications provided

Responsible Party: Jin Li, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01322152     History of Changes
Other Study ID Numbers: XELIRIcrc
Study First Received: March 23, 2011
Last Updated: June 10, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
metastases
neoplasm

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Capecitabine
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 29, 2014