AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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
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.

  1. Maximum tolerated dose of vandetanib and temozolomide

  2. Adverse events profile

  3. Toxicity profile

  4. Response profile

  5. Time until any treatment-related toxicity

  6. Time until treatment-related grade 3+ toxicity

  7. Time until hematologic nadirs

  8. Time to progression

  9. Time to treatment failure

  10. 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.

  1. First posted28 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2010 (estimated)

Why it stopped: no enrollment

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
Enrolment
0 participants (actual)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in