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Status:

UNKNOWN

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

Lead Sponsor:

Federation Francophone de Cancerologie Digestive

Conditions:

Colorectal Cancer

Eligibility:

All Genders

75+ years

Phase:

PHASE2

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. Giv...

Detailed Description

OBJECTIVES: Primary * Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride wit...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • 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
  • PRIOR CONCURRENT THERAPY:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    78 Patients enrolled

    Trial Details

    Trial ID

    NCT00303745

    Start Date

    June 1 2006

    Last Update

    July 24 2008

    Active Locations (23)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (23 locations)

    1

    Centre Hospitalier d'Abbeville

    Abbeville, France, 80101

    2

    Polyclinique Bordeaux Nord Aquitaine

    Boucher, France, 33300

    3

    Centre Hospitalier Universitaire Ambroise Pare - Boulogne

    Boulogne, France, F-92104

    4

    Centre Hospitalier

    Chalon-sur-Saône, France, F-71321