Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor .
PURPOSE: This phase I trial is studying how well bevacizumab works in treating patients with advanced solid tumors.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. After the third dose of bevacizumab, patients may receive additional bevacizumab in combination with chemotherapy in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
Standard curative or palliative measures do not exist or are no longer effective OR treatment with standard chemotherapy plus bevacizumab is appropriate* NOTE: *It must be judged clinically appropriate by the treating physician to delay combination treatment for the 6 weeks needed for study participation
Patients with squamous cell non-small cell lung cancer are ineligible
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Absolute neutrophil count ≥ 2,000/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases are present)
Creatinine clearance ≥ 50 mL/min
No proteinuria at baseline
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 4 months after completion of study treatment
No arterial thromboembolic events within the past 6 months, including any of the following:
No venous thromboembolic event within the past 3 months
No clinically significant cardiovascular disease
No uncontrolled hypertension
No New York Heart Association class II or greater congestive heart failure
No serious cardiac arrhythmia requiring medication
No presence of bleeding diathesis or coagulopathy
No significant traumatic injury within the past 4 weeks
No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
PRIOR CONCURRENT THERAPY:
No administration of nitrates within the past week
At least 2 weeks since prior and no concurrent antihypertensive agent(s)
No open biopsy within the past 14 days
No fine needle aspirations other than in the breast within the past 7 days
No placement of a vascular access device within the past 7 days
No major surgical procedure within the past 4 weeks
No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) and recovered
No radiotherapy within the past 4 weeks
No previous treatment with bevacizumab
No need for major surgical procedure during the course of the study
No other cancer immunotherapy or biologic therapy while on the study
No concurrent or recent (within past 10 days) use of full-dose oral or parenteral anticoagulants (heparin > 10,000/day or an INR > 1.5) or thrombolytic agents
No chronic, daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Primary purpose
Allocation
Interventional model
Masking
27 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal