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Prostate CancerPhase 2NCT00757692

Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

A Phase 2 study testing Vandetanib and Bicalutamide in people with Prostate Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.

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

Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer Hypothesis There will be a PSA response when Vandetanib is given in combination with Bicalutamide in Chemotherapy Naive Hormone refractory… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Vandetanib and Bicalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
4 sitesCanada
Study dates
Jan 2009to Nov 2012
Phase
Phase 2
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a pathological diagnosis of adenocarcinoma of the prostate
  • Patients must have biochemically recurrent disease or metastatic disease that is asymptomatic or minimally symptomatic (total daily morphine dose < 30mg.day) for which no curative therapy exists.
  • Patients must have documented evidence od PSA progression while receiving androgen ablative therapy (i.e. must be hormone refractory). Progression is defined as the development of new metastatic lesions, or rising PSA defined as at least two rises in PSA at least 1 week apart. If the second PSA is not rising, a thrid PSA is required to show further increase; if not, a subsequent level must show further increase. The third (or subsequent) PSA confirming progression must be within 2 weeks of randomization.
  • The PSA must be => 2ug/L at the time of study entry.
  • ECOG performance status of 0 or 1
  • Age =>18 years
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  • Patients must have a life expectancy of at least 12 weeks
  • No Prior chemotherapy is permissible for hormone refractory disease. Chemotherapy may have been received in a neoadjuvant or adjuvant setting provided it was given 12 months prior to registration.
  • Hormone Therapy
  • Prior hormone therapy in the form of either medical or surgical castration is required. If the patient is receiving medical androgen abalation a castrate level of testosterone (1.7nmol/L) must be present. Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of registration. If the patients has discontinued the LHRH agonist, this must be restarted and a castrate level of testosterone must be present.
  • Prior use of nonsteroidal antiandrogens (including bicalutamide) is permitted but must have been discontinued 6 weeks prior to registration.
  • Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and registration in the trial. Exceptions will be made for limited field, single fraction palliative radiation to bone.
  • No concurrent treatment with steriods unless steriods have been ingested for 4 weeks prior to commencing study at a dose of less than or equal to an equivalent of prednisone 20mg per day.
  • No concurrent experimental trial medication is permitted. No prior use of VEGF/VEGFR or EGFR targeting agents for hormone refractory disease is permitted.
  • Laboratory Requirements- within 7 calendar days prior to registration Hematology: haemoglobin >= 100g/L neutrophils >=1.5 x 10(9)/L Platelets >=100 x 10(9)/L INR =<1.5 x upper limit of normal Biochemistry: AST, ALT = <1.5 x upperlimit of normal Bilirubin <1.5 x upper limit of normal Serum creatinine <1.5 x upper limit of normal
  • Baseline QTc (Bazett's) <480msec determined by the average of a least 3 consecutive electrocardiograms (ECG) taken within 5-10 mins of each other.
  • Patient consent must be obtained according to local institutional and/or University Research and Ethic Board (REB) requirements.
  • Patients must be accessible for treatment and follow up.
  • Protocol treatment is to begin within 7 calendar days of patient registration.

Who cannot join

  • Patients with a history of other invasive malignancy, except:adequately treated non melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for 3 years.
  • Patients with known brain metastases or leptomemingeal disease are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of nerologic and other adverse events.
  • History of allergic reactions and/or sensitivity attributed to compounds of similar chemical or biological composition to Vandetanib or other agents used in the study.
  • Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment including;myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina,cardiomyopathy, unstable ventricular arrhythmias,OTc (Bazett's) >480msec Uncontrolled hypertension (systolic >160, diatolic >100) Uncontrolled psychotic disorders, serious infections,peptic ulcer disease,history of bleeding diathesis
  • Upper gasrtointerstinal or other conditions that would preclude compliance with oral medication
  • Patients with immune deficiency are at increased risk of lethal infections when treated with Marrow-suppressive therapy. Therefore, HIV positive patients receiving combination ant-retroviral therapy are excluded from study because of possible risk of lethal infection and additionally because of the possible pharmacokinetic interactions with Vandetanib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
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  • Patients who require escalating amounts of narcotic therapy to control pain e.g. morphine equivalent dose >30mg/day) since these patients would more appropriately be offered systemic chemotherapy
  • Patients who require therapeutic anticoagulation with warfarin.
  • Patients who require the following medication:concomittant use of warfarin, Class 1A antiarrythmics (e.g., quinidine, procainamide, disopyramide) Class
  • 1C antiarrhythmics (e.g.,flecainide, propafenone), Class III antiarrhythmics (e.g., amiodarone, sotalol, ibutilide), antipsychotics (e.g., thioridazine, chlorpromazine, pimozide, haloperidol, droperidol), tri/tetracyclic antidepressants (e.g., amitriptyline, imipramine, maprotiline), ketoconazole, antiepileptics and macrolide antibiotics.
  • Patients who cannot stop ingestion of grapefruit/juice.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • BC Cancer Agency - Centre for Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase II Randomised Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer

Hypothesis There will be a PSA response when Vandetanib is given in combination with Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.

Read the detailed description

With the advent of PSA surveillance, many patients diagnosed with hormone refractory disease, have PSA rising disease only, are asymptomatic, with no evidence of metastatic disease. There is no standard of care in this patient population. A standard treatment in this population has been the addition of a non-steroidal anti androgen such as bicalutamide. PSA response rate (defined as a 50% decrease) have been reported in 20% range with bicalutamide.

Even in patients with hormone refractory prostate cancer (HRPC) and metastases that have no cancer related symptoms, initiation of chemotherapy is controversial given the palliative nature of chemotherapy and potential for serious toxicity.

These patients are generally well enough to to undergo trials of novel agents and achieve adequate drug exposure, such that any cytostatic effect will be apparent.

Conditions
Prostate Cancer
Being tested
Vandetanib, Bicalutamide
Keywords
Vandetanib (ZD6474), Hormone, Refractory, Prostate Cancer, Chemotherapy, Naïve
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • VandetanibDrug

    Vandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously

  • BicalutamideDrug

    Bicalutamide at 50 mg will be administered orally, daily and continuously.

Study groups in NCT00757692
Study groupRoleWhat they receive
AExperimentalVandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously
Receives: Drug: Vandetanib
BActive comparatorBicalutamide at 50 mg will be administered orally, daily and continuously.
Receives: Drug: Bicalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA response

    Measured: Continuous to end of study

Secondary outcomes (2)

  1. time to over all progression

    Measured: continuous

  2. Evaluation of treatment related toxicity

    Measured: continuous

Timeline

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

  1. First posted23 Sep 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionFeb 2012
  4. Study completionNov 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00757692
Sponsor's protocol ID
OZM-011
Status last verified
Feb 2013
First submitted
19 Sep 2008
Last updated
20 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vandetanib and Bicalutamide in people with Prostate Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.

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

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

PSA response (time frame: Continuous to end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00757692.

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 20 Feb 2013.

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