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Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

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: NCT00303745
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2006
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

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

Detailed Description:



  • Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine.


  • Compare the tolerability of these regimens in these patients.
  • Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens.
  • Compare the progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), number of associated comorbidities (Charlson index 0-2 vs > 2), and age (75-79 vs ≥ 80). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 12 weeks thereafter.

After completion of study therapy, patients are followed every 12 weeks.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
Study Start Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective response
  2. Stable disease rate

Secondary Outcome Measures :
  1. Tolerability
  2. Quality of life
  3. Progression-free and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum

    • Unresectable disease
    • Documented progressive disease during first-line/palliative chemotherapy
  • Measurable disease ≥ 1 cm that is outside prior radiation field
  • No brain metastases


  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • No contraindication to chemotherapy
  • Creatinine clearance ≥ 40 mL/min
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement)
  • Bilirubin ≤ 1.5 times normal
  • Transaminases ≤ 5 times normal
  • No symptomatic coronary disease or cardiac insufficiency
  • No enteropathy or chronic diarrhea
  • No unresolved intestinal occlusion or subocclusion
  • No history of severe unexpected reaction to a fluoropyrimidine
  • No other active malignancy in the past 2 years
  • No hypersensitivity to irinotecan hydrochloride or its excipients
  • No hypersensitivity to capecitabine or fluorouracil


  • See Disease Characteristics
  • No prior extensive resection
  • No concurrent sorivudine or similar analogs (e.g., brivudine)
  • No other concurrent anticancer therapy
  • Concurrent radiotherapy allowed for nontarget lesions

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): NCT00303745

Show Show 23 study locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
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OverallOfficial: Emmanuel Mitry, MD, PhD Hopital Ambroise Pare
Study Chair: Thomas Aparicio Hopital Bichat - Claude Bernard
Layout table for additonal information Identifier: NCT00303745    
Other Study ID Numbers: CDR0000453857
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer
adenocarcinoma of the rectum
recurrent rectal cancer
stage IV rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors