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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00416637

Bevacizumab in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing Bevacizumab (Avastin) in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Herbert Hurwitz, MD.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab (Avastin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
Jan 2004to Mar 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor
  • Metastatic or unresectable disease
  • 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
  • Patients with ≥ 1+ proteinuria during screening should undergo a timed 12- or 24-hour urine collection, which must be an adequate collection and must demonstrate < 500 mg protein/24 hr to be eligible for the study
  • Not pregnant or nursing
  • No nursing for ≥ 4 months after completion of study treatment
  • 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:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
  • Clinically significant peripheral vascular disease
  • 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
  • Atrial or supraventricular tachycardias that are well controlled with beta blockers or calcium channel blockers are allowed
  • Chronic pacemakers allowed
  • 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)
  • Must have stable blood pressure (BP) (BP < 160/100 mm Hg) within the past 2 weeks
  • Must be asymptomatic within the past 2 weeks
  • 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
  • 1 mg of warfarin is permitted as required to maintain patency of preexisting, permanent indwelling IV catheters
  • 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)

About this study

Official title: Biomarker and Clinical Evaluation of Bevacizumab (Avastin) to Determine the Role of Nitric Oxide in Anti-VEGF Therapy

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether anti-vascular epidermal growth factor (VEGF) treatment comprising bevacizumab causes changes in endothelial cell function, as measured by brachial reactivity, and changes in nitric oxide (NOx), as measured by plasma/urinary/exhaled NOx levels, in patients with advanced solid tumors.
  • Determine whether anti-VEGF-related changes in blood pressure correlate with changes in brachial reactivity and NOx levels.

Secondary

  • Evaluate anti-angiogenic effects of bevacizumab in neovascular tissue in the wound angiogenesis model.
  • Correlate inhibition of wound angiogenesis with changes in VEGF-receptor 2 phosphorylation status and changes in NOx synthase expression.
  • Describe the mean and associated variability of other plasma and urine markers known to be associated with vascular reactivity, endothelial function, and/or tumor angiogenesis.
  • Describe, preliminarily, whether these changes correlate with changes in blood pressure, brachial reactivity, NOx levels, or wound angiogenesis.

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.

Being tested
Bevacizumab (Avastin)
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab (Avastin)Biological

Study groups in NCT00416637
Study groupRoleWhat they receive
Bevacizumab (Avastin)ExperimentalBevacizumab given and then BP checked and skin biopsies obtained.
Receives: Biological: Bevacizumab (Avastin)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2006 (estimated)
  2. Study startJan 2004
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416637
Sponsor's protocol ID
Pro00008011
Other IDs
DUMC-4907-05-6R2, GENENTECH-DUMC-4907-05-6R2, CDR0000449969
Status last verified
Jul 2016
First submitted
27 Dec 2006
Last updated
7 Jul 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bevacizumab (Avastin) in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Herbert Hurwitz, MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.

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Clinical Trial NCT00416637 | AzTrials