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Male Breast CancerPhase 1NCT00937482

Cediranib Maleate and Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer

A Phase 1 study testing cediranib maleate and whole-brain radiation therapy in people with Male Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of cediranib maleate when given together with whole brain radiation therapy in treating patients with brain metastases from non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cediranib maleate and whole-brain radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2009to Mar 2011
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

Who may be able to join

  • Patients must have one of the following histologically or cytologically confirmed cancers diagnosed no less than 12 weeks prior to study enrollment: non-small cell lung cancer, breast cancer, melanoma, colorectal cancer, or renal cell cancer
  • Patients must have >= 1 radiologically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastasis
  • Patients must have had no prior therapy for brain metastases with the exception of craniotomy for resection of brain metastases within 8 weeks of study entry
  • At least 2 weeks since last prior radiotherapy or chemotherapy (6 weeks if the last regimen included nitrosoureas, mitomycin C or bevacizumab)
  • At least 4 weeks since last surgery
  • There is no limit to the number of extracranial sites of disease
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  • Karnofsky performance status >= 70%
  • Life expectancy of greater than 8 weeks
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 x upper limit of reference range (ULRR)
  • AST (SGOT)/ALT (SGPT) =< 2.5 x ULRR or =< 5 x ULRR for patients with liver metastases
  • Creatinine =< 1.5 x ULRR or creatinine clearance >= 50 mL/min calculated by Cockcroft-Gault for patients with creatinine levels > 1.5 x ULRR
  • Patients must have a mini-mental status exam (MMSE) score >= 15
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of child-bearing potential must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas, mitomycin C or bevacizumab) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
  • Patients receiving any other investigational agents or who have participated in an investigational therapeutic trial within the past 30 days
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
  • Patients taking enzyme-inducing antiepileptic drugs (EIAED); patients may be on non-enzyme-inducing antiepileptic drugs (NEIAED) or may be on no antiepileptic drugs (AED); patients off EIAED for >= 2 weeks are eligible
  • Although the following medications are not contra-indicated on this study, each should be used with extreme caution, due to potential nephrotoxic effects: vancomycin, amphotericin, pentamidine
  • Patients who have leptomeningeal disease as the only site of CNS involvement are excluded, because disease progression is difficult to evaluate and standard treatment options and the extent of radiation may differ
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  • Patients taking oral anticoagulant drugs are excluded; patients may be taking low molecular weight heparin
  • Patients with a mean corrected QT interval > 470 milliseconds (with Bezett's correction) or patients with familial prolonged QT syndrome
  • Patients with > 1+ proteinuria on two successive urine dipstick assessments taken no less than 7 days apart, unless urinary protein is < 1.5 g in a 24-hour period; if first urinalysis shows no protein, then a repeat urinalysis is NOT required
  • Patients with significant hemorrhage (> 30mL bleeding per episode in previous 3 months) or hemoptysis (> 5mL fresh blood in previous 4 weeks)
  • Patients who have brain imaging (CT or MRI) evidence of acute intra- or peri- tumoral hemorrhage > grade 1; patients with punctuate hemorrhage or hemosiderin deposition are eligible
  • Patients who cannot undergo MRI safely
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, uncontrolled hypertension (> 140 systolic or > 90 diastolic mm Hg), New York Heart Association class III or IV heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with conditions requiring concurrent drugs or biologics with proarrhythmic potential
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD2171
  • HIV-positive patients on combination antiretroviral therapy are ineligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Phase 1 Study of AZD2171 and WBRT in Patients With Brain Metastases

This phase I trial is studying the side effects and best dose of cediranib maleate when given together with whole brain radiation therapy in treating patients with brain metastases from non-small cell lung cancer. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays and other types of radiation to kill cancer cells and shrink tumors. Giving cediranib maleate together with radiation therapy may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety and tolerability (maximum tolerated dose, or MTD) of AZD2171 when combined with WBRT in patients with brain metastases.

SECONDARY OBJECTIVES:

  1. To describe the objective response rate (ORR) in the central nervous system (CNS), neurologic progression-free survival (N-PFS), overall survival, and cause of death, and to explore the vascular normalization window using serial, noninvasive imaging parameters.

OUTLINE:

Patients receive oral cediranib maleate on day 1. Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 3. Treatment continues treatment in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Being tested
cediranib maleate, whole-brain radiation therapy
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colonic Neoplasms, Rectal Neoplasms, Brain Neoplasms

What participants receive

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

  • cediranib maleateDrug

    Also called AZD2171, Recentin

    Given orally

  • whole-brain radiation therapyRadiation

    Also called WBRT, whole-brain radiotherapy

    Undergo whole-brain radiotherapy

Study groups in NCT00937482
Study groupRoleWhat they receive
Treatment (cediranib maleate and WBRT)ExperimentalPatients receive oral cediranib maleate on day 1. Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 3. Treatment continues treatment in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cediranib maleate; Radiation: whole-brain radiation therapy

What is being measured

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

  1. MTD defined as the dose at which no patients develop treatment-related grade 5 toxicity and less than 30% of patients develop acute dose limiting toxicities (DLT) assessed using NCI CTCAE version 4.0

    Measured: 7 weeks

Secondary outcomes (5)

  1. Objective response in the CNS

    Measured: Up to 1.5 years

  2. Neurologic progression-free survival

    N-PFS will be summarized using a Kaplan-Meier survival curve.

    Measured: Time from start of treatment to time of progression in the CNS, assessed up to 1.5 years

  3. Overall survival

    Overall survival will be summarized using a Kaplan-Meier survival curve.

    Measured: From study entry until death due to any cause, assessed up to 1.5 years

  4. Cause of death

    The proportion of patients who fall into each category will be tabulated.

    Measured: Up to 1.5 years

  5. Vascular MRI studies

    Measured: Up to 1.5 years

Timeline

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

  1. First posted13 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMar 2011

Why it stopped: Administratively complete.

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937482
Sponsor's protocol ID
NCI-2013-00575
Other IDs
09-089, U01CA062490
Status last verified
Mar 2013
First submitted
9 Jul 2009
Last updated
8 Mar 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cediranib maleate and whole-brain radiation therapy in people with Male Breast Cancer and Stage IV Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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 17 inclusion and 16 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: stopped early, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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 stopped early (reason given: Administratively complete.). Results are not available in the source record.

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?

MTD defined as the dose at which no patients develop treatment-related grade 5 toxicity and less than 30% of patients develop acute dose limiting toxicities (DLT) assessed using NCI CTCAE version 4.0 (time frame: 7 weeks). 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 NCT00937482.

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 8 Mar 2013.

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