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Brain MetastasesPhase 2NCT01218529

Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors

A Phase 2 study testing Lapatinib in people with Brain Metastases and Lung Tumors, run by Hellenic Cooperative Oncology Group at 13 sites in Greece.

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

This phase II open-label study will be performed to evaluate the response rate of brain metastases from lung and breast tumors under treatment with WBRT and lapatinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, Lung Tumors, Breast Tumors
What is being tested?
Lapatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
13 sitesGreece
Study dates
Oct 2010to Dec 2014
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent;
  • Age >=18 years old;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
  • Life expectancy of at least 12 weeks;
  • Subjects must have histologically or cytologically confirmed invasive lung or breast cancer, with Stage IV disease;
  • Epidermal growth factor receptor (ErbB1/EGFR) overexpressing primary tumour, defined as 2+/3+ staining by immunohistochemistry (IHC) is mandatory to assess the patient population, but it is not a requirement for study entry.
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  • At least one measurable lesion in the brain, defined as any lesion >= 10mm in longest dimension on T1-weighted, gadolinium-enhanced MRI;
  • Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. Multigated acquisition scan (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive;
  • At least 3 weeks since last chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for cancer, and sufficiently recovered or stabilized from side effects associated with prior therapy. Concurrent treatment with bisphosphonates is permitted;
  • At least 3 weeks since major surgical procedures;
  • Able to swallow and retain oral medications;
  • Female subjects with child bearing potential or male subjects able to father a child must be completely abstinent from intercourse or use acceptable methods for birth control during the course of the study;
  • Subjects must complete all screening assessments as outlined in the protocol;
  • Subjects must have normal organ and marrow function as defined below:
  • SYSTEM LABORATORY VALUES Hematologic Absolute neutrophil count (ANC) 1.0 x 109/L Hemoglobin >= 9 g/dL (after transfusion if needed) Platelets >= 50 x 109/L Hepatic Albumin >= 2.5 g/dL Serum bilirubin <= 1.5x ULN unless due to Gilbert's syndrome Aspartate aminotransferase (AST) and Alaninine Aminotransferase (ALT) <= 5x upper limit of normal (ULN) if documented liver metastases <= 3x ULN without liver metastases Renal Serum Creatinine <= 2.0 mg/dL or Calculated Creatinine Clearance >= 25 mL/minCalculated by the Cockcroft and Gault Method

Who cannot join

  • Subjects are suitable for brain surgery or stereotactic radiosurgery (SRS);
  • Subjects who have had prior cranial radiotherapy. Prior radiotherapy for lesions outside CNS is allowed.
  • Subjects who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
  • Concurrent treatment with an investigational agent or participation in another treatment clinical trial;
  • Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their non-CNS cancer. Concurrent treatment with bisphosphonates is allowed;
  • Subjects with leptomeningeal carcinomatosis as the only site of CNS involvement;
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  • History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib;
  • Concurrent treatment with medications that are either inducers or inhibitors of CYP3A4 is prohibited. (For important exceptions, refer to Section Prohibited Medications);
  • Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded;
  • Any underlying liver or biliary disease (except for patients with Gilbert syndrome, asymptomatic cholelithiasis, liver metastases or stable chronic liver disease according to the physician)
  • Other known contraindication to MRI, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel;
  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety;
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  • Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel, CNS vasculitis, or malignant hypertension;
  • Active cardiac disease, defined as one or more of the following:
  • History of uncontrolled or symptomatic angina
  • History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
  • Myocardial infarction < 6 months from study entry
  • Uncontrolled or symptomatic congestive heart failure
  • Ejection fraction below the institutional normal limit
  • Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
  • Uncontrolled infection;
  • History of other malignancy, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects with other malignancies who have been disease-free for at least 5 years are eligible;
  • Pregnant or lactating females.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Greece13 sites

  • General Hospital of Athens 'Hippokratio', 2nd Dept of Internal Medicine

    Athens, 11527

  • Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit

    Athens, 11527

  • General Peripheral Hospital of Athens "Alexandra"

    Athens, 11528

  • Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology

    Athens, 14564

  • Hygeia Hospital, 1st Dept of Medical Oncology

    Athens, 15123

  • Hygeia Hospital, 2nd Dept of Medical Oncology

    Athens, 15123

  • Metropolitan Hospital, 1st Dept of Medical Oncology

    Athens, 18547

  • Metropolitan Hospital, 2nd Dept of Medical Oncology

    Athens, 18547

  • Chania General Hospital, Oncology Section

    Chania, 73100

  • Ioannina University Hospital, Dept of Medical Oncology

    Ioannina, 45110

  • University Hospital of Larissa, Dept of Internal Medicine, Oncology Section

    Larissa, 44110

  • Rio University Hospital, Dept of Medical Oncology

    Pátrai, 26500

  • Papageorgiou General Hospital, Dept of Medical Oncology

    Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Lapatinib and Whole Brain Radiotherapy for Patients With Brain Metastases From Lung and Breast Tumors. A Phase II Study of the Hellenic Cooperative Oncology Group (HeCOG).

This phase II open-label study will be performed to evaluate the response rate of brain metastases from lung and breast tumors under treatment with WBRT and lapatinib.

Read the detailed description

Patients with breast or lung cancer who have developed brain metastases will be treated with WBRT (30Gy in 10 fractions) and lapatinib 1250mg once daily, followed by lapatinib treatment 1500mg once daily for a total duration of 6 weeks. At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients. Subsequent to the 6 weeks treatment period with lapatinib, the patients may discontinue lapatinib as monotherapy and the physicians can proceed with any therapy, according to their discretion. The patients will be followed-up every 12 weeks for disease progression and survival.

Being tested
Lapatinib
Keywords
Brain metastases from lung and breast tumors
Medical subject headings
Brain Neoplasms, Lung Neoplasms, Breast Neoplasms

What participants receive

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

  • LapatinibDrug

    Co-administration of lapatinib 1250mg once daily during the WBRT period (2 weeks)and then monotherapy with lapatinib 1500mg once daily for 4 weeks.

Study groups in NCT01218529
Study groupRoleWhat they receive
Whole Brain Radiation Therapy (WBRT) + lapatinibExperimentalWhole Brain Radiation Therapy (30Gy in 10 fractions) and lapatinib 1250mg once daily for 2 weeks followed by lapatinib treatment 1500mg once daily for 4 weeks.
Receives: Drug: Lapatinib

What is being measured

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

  1. Response rate in brain as assessed by volumetric analysis of brain Mangnetic Resonance Imaging (MRI).

    Measured: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients

Secondary outcomes (4)

  1. Response rate for systemic disease

    Chest, abdomen, and pelvic Computerized Tomography (CT) scans will be performed at the 6 weeks timepoint to evaluate the response for systemic disease

    Measured: At 6 weeks

  2. Time To Progression in brain and/or non-Central Nervous System (CNS)

    Measured: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients.The patients will be followed-up every 12 weeks for disease progression and survival.

  3. Safety and tolerability of proposed schema. Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.

    Adverse Events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient.

    Measured: 10 weeks (6 weeks therapy + 4 weeks follow-up period for AEs)

  4. To explore the 20% volumetric reduction of brain metastatic lesions as a meaningful threshold of CNS response.

    Measured: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients.

Timeline

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

  1. First posted11 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2014
  4. Study completionDec 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218529
Sponsor's protocol ID
HE 42/09
Other IDs
2009-013128-22, 2009
Status last verified
Dec 2014
First submitted
8 Oct 2010
Last updated
31 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lapatinib in people with Brain Metastases and Lung Tumors, run by Hellenic Cooperative Oncology Group at 13 sites in Greece.

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 15 inclusion and 24 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Greece. 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?

Response rate in brain as assessed by volumetric analysis of brain Mangnetic Resonance Imaging (MRI). (time frame: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients). 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 NCT01218529.

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 31 Dec 2014.

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