Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 10, 2001
Last updated: July 23, 2008
Last verified: February 2005

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Xeloda in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Detailed Description:


  • Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.
  • Determine the time to treatment failure, time to overall response, duration of overall complete response, and time to progression in patients treated with this regimen.
  • Determine the 1-year survival and overall survival of patients treated with this regimen.
  • Determine the toxicity and safety profile of this regimen in these patients.
  • Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma
  • At least 1 measurable lesion

    • At least 10 mm by spiral CT scan
    • At least 20 mm by conventional techniques
    • Bone metastases, ascites, or pleural effusions are not considered measurable disease
  • No evidence of CNS metastases



  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified


  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present)
  • No known Gilbert's disease


  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min


  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias uncontrolled with medication
  • No myocardial infarction within the past 12 months


  • Able to swallow tablets
  • No lack of physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome


  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No hypersensitivity to fluorouracil
  • No history of uncontrolled seizures or CNS disorders
  • No psychological illness or condition that would preclude study entry
  • No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy
  • No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer
  • No concurrent prophylactic hematopoietic growth factors


  • At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy
  • No prior chemotherapy for metastatic colorectal cancer
  • No prior irinotecan or capecitabine
  • No other concurrent cytotoxic agents

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed)
  • No concurrent radiotherapy


  • At least 4 weeks since prior major surgery and recovered
  • No prior organ allograft


  • At least 4 weeks since prior participation in an investigational drug study
  • No other concurrent investigational drugs
  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 identifier: NCT00022698

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States, 32209
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
United States, Missouri
St. Louis University Hospital Cancer Center
Saint Louis, Missouri, United States, 63110-0250
United States, New York
Lincoln Medical and Mental Health Center
Bronx, New York, United States, 10451
HemOnCare, P.C.
Brooklyn, New York, United States, 11235
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States, 29403
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98104
Rockwood Clinic P.S.
Spokane, Washington, United States, 99202
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Mike Andria Hoffmann-La Roche
  More Information

Publications: Identifier: NCT00022698     History of Changes
Other Study ID Numbers: CDR0000068843  ROCHE-ML16323 
Study First Received: August 10, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on February 10, 2016