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Status:

COMPLETED

Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Lead Sponsor:

Federation Francophone de Cancerologie Digestive

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-74 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizuma...

Detailed Description

OBJECTIVES: Primary * Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy. * Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this tre...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of metastatic adenocarcinoma of the colon or rectum
  • Not curable by surgery
  • Genotype UGT1A1\*1/UGT1A1\*1 or UGT1A1\*1/ UGT1A1\*28
  • Measurable disease
  • No original tumor in place
  • No secondary cerebral metastases
  • PATIENT CHARACTERISTICS:
  • Inclusion criteria:
  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 times normal
  • Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients of must use effective contraception
  • Exclusion criteria:
  • Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6 months
  • Enteropathy or chronic diarrhea
  • Proteinuria \> 500 mg/24 hours
  • Active cardiac disease
  • Uncontrolled hypertension
  • Myocardial infarction in the past 12 months
  • Angina
  • NYHA grade II-IV congestive heart disease
  • Severe arrhythmia even with treatment
  • Peripheral vascular disease ≥ grade II
  • Nonhealing wound, ulcer, or severe bone fracture
  • Hemorrhagic diatheses or coagulopathy
  • Severe or uncontrolled infection
  • Severe or uncontrolled medical condition
  • Other malignant disease in the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the uterine cervix
  • Severe traumatic injury within the past 4 weeks
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy for metastatic disease
  • One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the original tumor allowed
  • At least 6 months since prior chemotherapy
  • No prior irinotecan hydrochloride or bevacizumab
  • No oral or parenteral anticoagulant therapy within the past 10 days
  • Warfarin allowed provided INR \< 1.5
  • No major surgery or biopsy within the past 4 weeks
  • No puncture in the past 7 days
  • No planned major surgery
  • No concurrent daily or chronic aspirin (\> 325 mg/day), anti-inflammatories, or steroids
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2008

    Estimated Enrollment :

    86 Patients enrolled

    Trial Details

    Trial ID

    NCT00628810

    Start Date

    January 1 2007

    End Date

    December 1 2008

    Last Update

    November 9 2020

    Active Locations (32)

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    Page 1 of 8 (32 locations)

    1

    Centre Hospitalier d'Abbeville

    Abbeville, France, 80101

    2

    Centre Hospitalier Universitaire d'Amiens

    Amiens, France, 80054

    3

    Hopital Duffaut

    Avignon, France, 84902

    4

    C.H.G. Beauvais

    Beauvais, France, 60021