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Status:

COMPLETED

Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

Lead Sponsor:

Herbert Hurwitz

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Detailed Description

OBJECTIVES: Primary * Determine the response rate in patients with unresectable metastatic or recurrent colorectal adenocarcinoma treated with capecitabine, cetuximab, oxaliplatin, and bevacizumab. ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Unresectable disease
  • Metastatic or recurrent disease
  • Not amenable to potentially curative treatment
  • No untreated leptomeningeal or brain metastases
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No known uncontrolled coagulopathy
  • Hepatic
  • AST and ALT \< 2.5 times upper limits of normal (ULN) (5 times ULN if liver metastases are present)
  • Bilirubin \< 2.0 times ULN
  • Renal
  • Creatinine clearance \> 40 mL/min
  • Urine protein negative
  • Urine protein:creatinine ratio \> 1
  • Cardiovascular
  • No unstable or uncontrolled hypertension (i.e., blood pressure \[BP\] \> 150/100 mm Hg despite antihypertensive therapy)
  • Patients who recently started or have adjusted antihypertensive medications are eligible provided BP is \< 140/90 mm Hg for ≥ 3 different measurements over 14 days
  • No arterial thromboembolic events within the past 6 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
  • Clinically significant peripheral vascular disease
  • No New York Heart Association class III-IV congestive heart failure
  • No uncontrolled symptomatic coronary artery disease or cardiac arrhythmia
  • No other significant uncontrolled cardiac disease
  • Gastrointestinal
  • No lack of physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome
  • No inability to tolerate oral medication
  • Immunologic
  • No prior severe infusion reaction to a monoclonal antibody
  • No history of an allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, cetuximab, capecitabine, or bevacizumab
  • No prior unanticipated, severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluoroucacil
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during the study and for 3-4 months after completion of study treatment
  • No peripheral neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No known dihydropyrimidine dehydrogenase deficiency
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior adjuvant bevacizumab or cetuximab
  • No other concurrent anticancer immunotherapy or biologic therapy
  • Chemotherapy
  • At least 6 months since a prior adjuvant fluorouracil-, leucovorin calcium-, or capecitabine-based regimen
  • At least 12 months since prior adjuvant oxaliplatin
  • No prior chemotherapy for metastatic or recurrent disease
  • Endocrine therapy
  • No concurrent hormonal therapy
  • Radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • More than 4 weeks since prior major surgery and recovered
  • More than 6 months since vascular surgery, stenting, or angioplasty
  • Other
  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • More than 4 weeks since prior participation in any investigational drug study
  • No prior therapy that affects or targets the epidermal growth factor pathway
  • No concurrent cimetidine
  • Concurrent ranitidine, famotidine, or proton-pump inhibitors allowed
  • Concurrent anticoagulation therapy with full-dose anticoagulant allowed provided dose is stable for at least 2 weeks

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2011

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00290615

    Start Date

    January 1 2006

    End Date

    January 1 2011

    Last Update

    May 7 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710

    2

    Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, United States, 27157-1096