Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00601614
Vandetanib and Temozolomide in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
A Phase 1 study testing temozolomide, vandetanib and immunoenzyme technique in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Mayo Clinic.
Trial summary
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… 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?
- temozolomide, vandetanib and immunoenzyme technique
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2010
- 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
- Unresectable, advanced disease
- Measurable or evaluable disease
- No known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
- No intracranial metastatic disease, unless it has been radiologically and clinically stable for the past 3 months
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/μL
- Absolute lymphocyte count > 1,000/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
- Creatinine ≤ 1.5 times ULN OR creatinine clearance > 50 mL/min
- Potassium normal
- Serum calcium (ionized or adjusted for albumin) normal
- Magnesium normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No currently active diarrhea that results in an ongoing need for IV fluids and/or that may affect the ability of the patient to absorb vandetanib or tolerate diarrhea
- No evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or that would jeopardize compliance with the study
- No other malignancies within the past 5 years, except cervical carcinoma in situ or adequately treated basal cell or squamous cell carcinoma of the skin
- No clinically significant cardiac event, such as myocardial infarction, NYHA class II-IV heart disease within the past 3 months, or presence of cardiac disease that, in the opinion of the treating physician, increases the risk of ventricular arrhythmia
- No history of arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (CTCAE grade 3)
- Atrial fibrillation that is controlled on medication allowed
- No asymptomatic sustained ventricular tachycardia
- No history of QTc prolongation as a result of other medication that required discontinuation of that medication
- No congenital long QT syndrome
- No 1st degree relative with unexplained sudden death under 40 years of age
- No left bundle branch block
- No QTc with Bazett's correction that is unmeasurable
- QTc < 480 msec on screening ECG
- No hypertension that is uncontrolled by medical therapy (i.e., systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg)
- No bleeding diathesis (inherited coagulopathy)
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 30 days since prior investigational agents
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
- More than 4 weeks since prior immunotherapy or biologic therapy
- More than 4 weeks since prior major surgery
- Surgical incision must be completely healed
- More than 4 weeks since prior radiotherapy, except palliative radiotherapy
- No prior radiotherapy to > 25% of bone marrow
- No prior temozolomide or dacarbazine
- No prior enrollment in this study
- More than 2 weeks since prior and no concurrent known potent CYP3A4 inducers, such as rifampin, phenytoin, carbamazepine, barbiturates, or St. John's wort
- More than 2 weeks since prior and no concurrent drugs associated with an increased risk of causing Torsades de Pointes
- No concurrent medication that may cause QTc prolongation
- No concurrent anticoagulants
- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
About this study
Official title: Phase I Study of ZD6474 and Temozolomide in Patients With Advanced Cancer
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and temozolomide in treating patients with advanced solid tumors that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- To determine the maximum tolerated dose of concurrently administered vandetanib and temozolomide in patients with unresectable, advanced solid tumors.
- To describe the toxicity profile of this regimen in these patients.
- To describe the response rate in patients treated with this regimen.
- To describe the effects of therapy on angiogenesis-related translational endpoints.
OUTLINE: Patients receive escalating doses of oral vandetanib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and prior to each treatment course for correlative laboratory studies, including evaluation of plasma VEGF levels by ELISA, serum angiogenesis assay, and measurement of circulating endothelial cell populations (CD133, CD34, CD146). Frozen serum and plasma samples are also stored for future research studies.
- Being tested
- temozolomide, vandetanib, immunoenzyme technique, laboratory biomarker analysis
- 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.
temozolomideDrug
vandetanibDrug
immunoenzyme techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of vandetanib and temozolomide
Adverse events profile
Toxicity profile
Response profile
Time until any treatment-related toxicity
Time until treatment-related grade 3+ toxicity
Time until hematologic nadirs
Time to progression
Time to treatment failure
Correlation of changes in VEGF levels, serum angiogenesis, and circulating endothelial cells with response and dose levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010 (estimated)
Why it stopped: no enrollment
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ravi D. Rao, MD, MBBS, Study chair, Mayo ClinicSvetomir Markovic, MD, PhD, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601614
- Sponsor's protocol ID
- MC0615
- Other IDs
- MAYO-MC0615, MC0615, MAYO-07-004966
- Status last verified
- Mar 2014
- First submitted
- 24 Jan 2008
- Last updated
- 10 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of ZD6474 and Temozolomide in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00601614
- Acronym / sponsor ID
- MC0615
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 28 Jan 2008 (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: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and temozolomide in treating patients with advanced solid tumors that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- To determine the maximum tolerated dose of concurrently administered vandetanib and temozolomide in patients with unresectable, advanced solid tumors.
- To describe the toxicity profile of this regimen in these patients.
- To describe the response rate in patients treated with this regimen.
- To describe the effects of therapy on angiogenesis-related translational endpoints.
OUTLINE: Patients receive escalating doses of oral vandetanib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and prior to each treatment course for correlative laboratory studies, including evaluation of plasma VEGF levels by ELISA, serum angiogenesis assay, and measurement of circulating endothelial cell populations (CD133, CD34, CD146). Frozen serum and plasma samples are also stored for future research studies.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| temozolomide | Drug | – |
| vandetanib | Drug | – |
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Maximum tolerated dose of vandetanib and temozolomide
Adverse events profile
Toxicity profile
Response profile
Time until any treatment-related toxicity
Time until treatment-related grade 3+ toxicity
Time until hematologic nadirs
Time to progression
Time to treatment failure
Correlation of changes in VEGF levels, serum angiogenesis, and circulating endothelial cells with response and dose levels
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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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.
Ravi D. Rao, MD, MBBS study chair
Mayo Clinic
Svetomir Markovic, MD, PhD
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing temozolomide, vandetanib and immunoenzyme technique in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Mayo Clinic.
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: withdrawn, as of the sponsor's last update on 10 Mar 2014. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Maximum tolerated dose of vandetanib and temozolomide. The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 10 Mar 2014.