Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00099060
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioblastoma multiforme
* Recurrent or progressive disease after prior primary treatment with radiotherapy with or without adjuvant chemotherapy
* Bidimensionally measurable disease on CT scan or MRI with at least one lesion ≥ 1 cm x 1 cm
* Paraffin embedded tumor sample available
* Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) required for phase I of the study
* Patients in phase II of the study may or may not be receiving EIAEDs
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* LVEF ≥ 50% by echocardiogram or MUGA
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No unstable angina
* No active cardiomyopathy
* No cardiac arrhythmia
* No uncontrolled hypertension
Pulmonary
* No pulmonary disease requiring oxygen
Neurologic
* No preexisting peripheral neuropathy ≥ grade 3
* No history of significant neurologic disorder that would preclude study compliance or ability to give informed consent
Gastrointestinal
* No upper gastrointestinal or other conditions that would preclude compliance with oral medication
* No active peptic ulcer disease
Other
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor
* No immune deficiency
* No history of significant psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude study compliance or ability to give informed consent
* No other serious illness or medical condition that would preclude study participation
* No known hypersensitivity to compounds of similar chemical or biological composition to lapatinib
* No active uncontrolled or serious infection
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other hematopoietic growth factors
* Concurrent hematopoietic growth factors allowed for treatment of acute toxicity (e.g., febrile neutropenia)
Chemotherapy
* See Disease Characteristics
* No prior chemotherapy for recurrent disease
* No more than one prior chemotherapy regimen in the adjuvant setting
* At least 6 months since prior adjuvant chemotherapy
Endocrine therapy
* Concurrent steroids allowed provided the dose is stable for at least 14 days before study entry
Radiotherapy
* See Disease Characteristics
* At least 6 weeks since prior radiotherapy
Surgery
* At least 2 weeks since prior major surgery
Other
* H2 blockers and proton pump inhibitors allowed, unless they are CYP3A4 inducers or inhibitors
* At least 7 days since prior and no concurrent administration of any of the following CYP3A4 inhibitors:
* Clarithromycin
* Erythromycin
* Troleandomycin
* Telithromycin
* Ciprofloxacin
* Norfloxacin
* Itraconazole
* Ketoconazole
* Voriconazole
* Fluconazole (≤150 mg/day allowed)
* Nefazodone
* Fluovoxamine
* Delavirdine
* Nelfinavir
* Amprenavir
* Ritonavir
* Indinavir
* Saquinavir
* Lopinavir
* Verapamil
* Diltiazem
* Aprepitant
* Grapefruit or grapefruit juice
* Bitter orange
* At least 14 days since prior and no concurrent administration of any of the following CYP3A4 inducers:
* Rifampin
* Rifabutin
* Rifapentine
* Efavirenz
* Nevirapine
* Hypericum perforatum (St. John's wort)
* Modafinil
* At least 6 months since prior and no concurrent administration of amiodarone
* Antacids (e.g., mylanta, maalox, tums, rennies) must be administered ≥ 1 hour before and ≥ 1 hour after study drug
* At least 2 days since prior and no concurrent cimetidine
* No other concurrent anti-cancer agents
* No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00099060
Study Brief:
Protocol Section:
NCT00099060