My sister was pre-screened for phase II of Lapatinib - clinical trial. I was able to set up a consutation app't for her on June 27th with Dr Harold Burstein at the Dana Farber Cancer institute in Boston.
Does anyone know how it is decided whether or not a patient is eligble for a trial?

oops! that should read phase III (not II)

Celina,

We wish your sister the best. All of our prayers will be with her. Thank God that she has a wonderful sister like you.


I have copied the criteria from the Clinical Trial website for the Dana Farber Trial:

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed invasive breast cancer
Stage IV disease
HER2-overexpressing disease, defined by 1 of the following:
3+ by immunohistochemistry (IHC)
2+ by IHC with HER2 gene amplification by fluorescent in situ hybridization (FISH)
HER2 gene amplification by FISH alone in patients whose tumor blocks were not assessed by IHC
At least one measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI
CNS metastases meeting criteria for 1 of the following:
Metastases previously treated with whole brain radiotherapy (WBRT) and/or stereotactic radiosurgery (SRS)
Asymptomatic metastases discovered on a screening radiological study without prior WBRT or SRS
Disease progression in the CNS, as defined by at least 1 of the following:
New neurological signs or symptoms
New lesions in the CNS on an imaging study
Progressive lesions on an imaging study
No leptomeningeal carcinomatosis as the only site of CNS metastases
Received prior trastuzumab (Herceptin®) alone or in combination with chemotherapy
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS: Age

18 and over
Sex

Female or male
Menopausal status

Not specified
Performance status

Karnofsky 60-100% OR
ECOG 0-2
Life expectancy

At least 12 weeks
Hematopoietic

Absolute neutrophil count ≥ 1,000/mm^3
Hemoglobin ≥ 9 g/dL (transfusion allowed)
Platelet count ≥ 75,000/mm^3
Hepatic

Albumin ≥ 2.5 g/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN) unless due to Gilbert’s syndrome
AST and ALT ≤ 5 times ULN
Renal

Creatinine ≤ 1.5 mg/dL OR
Creatinine clearance ≥ 25 mL/min
Cardiovascular

Ejection fraction normal by MUGA or echocardiogram
No preexisting severe cerebral vascular disease, such as stroke involving a major vessel, CNS vasculitis, or malignant hypertension
No history of uncontrolled or symptomatic angina
No history of arrhythmias requiring medication
No clinically significant arrhythmias, except asymptomatic atrial fibrillation requiring anticoagulation
No myocardial infarction within the past 6 months
No uncontrolled or symptomatic congestive heart failure
No other cardiac condition that would preclude study participation
Gastrointestinal

Able to swallow and retain oral medications
No malabsorption syndrome
No disease significantly affecting gastrointestinal function
No active ulcerative colitis
Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 weeks after study participation
No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug
No history of immediate or delayed hypersensitivity reaction to gadolinium contrast agents
No other contraindication to gadolinium contrast
No known contraindication to MRI (e.g., cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel)
No serious medical or psychiatric disorder that would preclude study participation
No dementia, altered mental status, or psychiatric condition that would preclude giving informed consent
No active or uncontrolled infection
No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No other disease or condition that would preclude study participation
PRIOR CONCURRENT THERAPY: Biologic therapy

See Disease Characteristics
At least 2 weeks since prior trastuzumab
At least 2 weeks since prior anticancer immunotherapy
At least 2 weeks since prior anticancer biologic therapy
No concurrent anticancer immunotherapy
No concurrent anticancer biologic therapy (including ErbB1 and/or ErbB2 inhibitors)
Chemotherapy

See Disease Characteristics
At least 2 weeks since prior anticancer chemotherapy
No concurrent anticancer chemotherapy
Endocrine therapy

At least 2 weeks since prior anticancer hormonal therapy
No concurrent anticancer hormonal therapy
Radiotherapy

See Disease Characteristics
At least 2 weeks since prior anticancer radiotherapy
No concurrent anticancer radiotherapy
Surgery

See Disease Characteristics
At least 3 weeks since prior major surgery
No prior resection of the stomach or small bowel
Other

Recovered from all prior therapy
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
Clarithromycin
Erythromycin
Troleandomycin
Roxithromycin
Telithromycin
Delaviridine
Ritonavir
Indinavir
Saquinavir
Nelfinavir
Amprenavir
Lopinavir
Itraconazole
Ketoconazole
Voriconazole
Fluconazole (doses of > 200 mg/day)
Nefazodone
Fluvoxamine
Verapamil
Diltiazem
Aprepitant
Grapefruit juice
At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
Phenytoin
Carbamazepine
Phenobarbital
Oxcarbazepine
Rifampin
Rifabutin
Rifapentene
Efavirenz
Nevirapine
Hypericum perforatum (St. John’s wort)
Modafinil
At least 6 months since prior and no concurrent amiodarone
Concurrent bisphosphonates allowed
No concurrent drugs that increase gastric pH
No concurrent cimetidine
No concurrent herbal supplements
No other concurrent investigational agents

Celina,

Please email your sister's name. I will send a letter of recommendation to Dana Farber. If your sister doesn't qualify for the trial, she may be eligable to receive Lapatinib under the compassioate drug program.

Joe@her2support.org


Regards
Joe

Joe,
Thank you so much...that is so considerate of you. Her name is Carole Zeyl. Her appointment is on June 27th at 1pm.
Thank you to everyone who has prayed for her in the past and present and to all of you who have continually wished her well.
I will let you know how things progress.
Celina

Celina -
That is SUCH wonderful news that Carole is prequalified for the Lapatinib trial. I will be waiting to hear about this with great interest. Will be sending best wishes for her to be accepted and do well with this very promising new drug.
Bon voyage!

Celina,
That's just great news and keep pushing to get your sister in. Every Cancer patient needs an advocate and your sister is so lucky to have you as hers.

Best to you and Carole,

Al