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Status:

TERMINATED

Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

Lead Sponsor:

Roswell Park Cancer Institute

Conditions:

Colorectal Cancer

Eligibility:

All Genders

70+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...

Detailed Description

OBJECTIVES: Primary * Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy. Secondary * Det...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically\* or cytologically\* confirmed colorectal cancer
  • Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery
  • Metastatic disease NOTE: \*Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of \> 5 years has elapsed between initial primary surgery and the development of metastases
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known curative therapy exists
  • No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases)
  • PATIENT CHARACTERISTICS:
  • Age
  • 70 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • No bleeding diathesis or coagulopathy
  • Hepatic
  • Bilirubin normal
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • INR \< 1.5 (unless on therapeutic anticoagulants)
  • No unstable or uncompensated hepatic disease
  • Renal
  • Creatinine \< 1.2 times ULN OR
  • Creatinine clearance \> 60 mL/min
  • No unstable or uncompensated renal disease
  • Cardiovascular
  • No history of stroke
  • No uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg on medication)
  • No myocardial infarction within the past year
  • No New York Heart Association class II-IV congestive heart failure
  • No unstable angina
  • No serious cardiac dysrhythmia requiring medication
  • No other clinically significant cardiovascular disease
  • No other unstable or uncompensated cardiac disease
  • Pulmonary
  • No unstable or uncompensated respiratory disease
  • Other
  • Fertile patients must use effective contraception
  • Able to receive oral medication
  • No known hypersensitivity to fluorouracil or capecitabine
  • No known dihydropyrimidine dehydrogenase deficiency
  • No seizures not controlled by standard medical therapy
  • No serious nonhealing wound, ulcer, or bone fracture
  • No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix
  • No other severe or uncontrolled systemic disease
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior bevacizumab
  • Chemotherapy
  • Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered \> 6 months before the development of metastatic disease
  • No prior chemotherapy for metastatic colon cancer
  • No prior irinotecan or oxaliplatin
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • See Disease Characteristics
  • More than 28 days since prior and no concurrent major surgery
  • More than 28 days since prior open biopsy
  • More than 7 days since prior fine needle aspiration or core biopsy
  • Other
  • More than 4 weeks since prior and no concurrent participation in another experimental drug study
  • More than 30 days since prior non-approved or investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    16 Patients enrolled

    Trial Details

    Trial ID

    NCT00107315

    Start Date

    July 1 2004

    Last Update

    July 4 2014

    Active Locations (1)

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    Roswell Park Cancer Institute

    Buffalo, New York, United States, 14263-0001