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.
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
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- 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 group | Role | What they receive |
|---|---|---|
| Bevacizumab (Avastin) | Experimental | Bevacizumab 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.
- First posted28 Dec 2006 (estimated)
- Study startJan 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Herbert Hurwitz, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Herbert Hurwitz, MD, Duke University
- Investigators
- Herbert I. Hurwitz, MD, Principal investigator, Duke Cancer Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker and Clinical Evaluation of Bevacizumab (Avastin) to Determine the Role of Nitric Oxide in Anti-VEGF Therapy
- ClinicalTrials.gov ID
- NCT00416637
- Acronym / sponsor ID
- Pro00008011
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Herbert Hurwitz, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab (Avastin) | Experimental | Biological: Bevacizumab (Avastin)Bevacizumab given and then BP checked and skin biopsies obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab (Avastin) | Biological | Bevacizumab (Avastin) |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert I. Hurwitz, MD principal investigator
Duke Cancer Institute
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.