araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Summary: Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  ErbB2(HER2)overexpressing breast cancer.
  -  Brain lesion(s) which are progressing.
  -  Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
  -  Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
  -  Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
  -  Able to swallow an oral medication.
  -  Adequate kidney and liver function.
  -  Adequate bone marrow function.
  Exclusion criteria:
  -  Pregnant or lactating females.
  -  Conditions that would effect the absorption of an oral drug.
  -  History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
  -  Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Metabolomic Analysis of Lung Cancer

Summary: The purpose of this study is to learn more about the metabolic properties of lung cancer cells.

Detailed description: It has long been known that cancer cells absorb and break down substances in the body differently than healthy, non-cancer cells. This process of absorbing and breaking down substances is known as metabolism and is increased in cancer cells. Recent research suggests that this increased metabolic activity makes it easier for cancer cells to multiply. The objective of the study is to characterize the metabolism of glucose by lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.

Eligibility: Lung Cancer Patients (Groups 1 & 2)
  Inclusion Criteria:
  -  patients with suspected, clinically diagnosed, or histologically diagnosed lung cancer. Occasionally, other cancers (including metastatic cancers to the lung) may be resected for the study as negative controls for NSCLC, as warranted by the particulars of the case.
  -  patients must have general medical conditions to allow them to undergo surgical resection of their primary tumor
  Exclusion Criteria:
  -  history of diabetes for the experimental group (surgery + glucose); patients with a history of diabetes are allowed in the control group (surgery/no glucose)
  -  known hepatitis C or HIV (AIDS)
  Healthy Subjects (Group 3)
  Inclusion Criteria:
  -  at least 30 years of age
  -  preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
  Exclusion Criteria:
  -  prior history of diagnosed lung cancer
  -  known hepatitis C or HIV (AIDS)

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Summary: The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Detailed description: This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC.
  WHAT IS SATRAPLATIN:
  Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed advanced NSCLC
  -  Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry.
  -  Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
  -  ECOG performance status of ≤ 2.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study of ARRY-334543 in Patients With Advanced Cancer

Summary: This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.
  This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
  In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).


Eligibility: Key Inclusion Criteria (Part 2):
  -  Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
  -  Measurable disease (at least 1 target lesion) according to modified RECIST.
  -  Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  -  Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
  -  Additional criteria exist.
  Key Exclusion Criteria (Part 2):
  -  Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
  -  Use of an investigational medication or device within 30 days prior to first dose of study drug.
  -  Major surgery within 30 days prior to first dose of study drug.
  -  Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
  -  Pregnancy or lactation.
  -  Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis B and/or hepatitis C.
  -  Additional criteria exist.

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

Summary: This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.


Eligibility: Inclusion Criteria:
  -  Age >= 18
  -  Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  -  Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
  -  Radiologically measurable or evaluable disease No prior chemotherapy
  -  1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
  -  Tumor tissue block or fine needle aspirate
  Exclusion Criteria:
  -  Any concurrent anticancer therapy or radiation
  -  Other active malignancy
  -  Uncontrolled brain metastases
  -  GI abnormalities
  -  Severe abnormalities of the cornea
  -  Significant cardiac disease
  -  Active infection

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lung Cancer Biomarkers and Screening

Summary: RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer.
  PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.

Detailed description: OBJECTIVES:
  -  Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
  -  Identify preneoplastic cellular changes and lesions in these patients.
  OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk).
  Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy.
  Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy.
  PROJECTED ACCRUAL: A total of participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Screening Cohort
  -  At high- or low-risk for lung cancer
  -  Smoking history ≥ 20 pack years*
  -  With or without workplace exposure to asbestos
  -  NOTE: * Participants with < 20 pack years of smoking are eligible if 50 years of age or older
  -  Rule-Out Lung cancer group
  -  Referred for evaluation of suspicious nodules with 1 of the following diagnoses:
  -  Lung cancer
  -  Nonmalignant nodules (control group)
  PATIENT CHARACTERISTICS:
  -  Not pregnant
  -  No prior malignancy except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer.
  PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who are undergoing treatment with erlotinib for stage III non-small cell lung cancer and have no CNS metastatic disease.
  OUTLINE: This is a pilot, nonrandomized study.
  Patients will undergo single lumbar puncture (LP) to remove cerebrospinal fluid for analysis.
  After completion of study, patients will be monitored for 1 month after LP to assess for any LP-related complications.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients must be enrolled in the trial: "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer," Principal Investigator: T. Mekhail, M.D.
  -  Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week
  -  No known CNS primary or metastatic cancer at any time prior to time of enrollment
  -  No MRI evidence of pathological enhancement at the time of study entry
  PATIENT CHARACTERISTICS:
  -  Patients must use adequate birth control measures while in the study
  -  No significant side effects to erlotinib that require dose reduction or interruption
  -  None of the following medical issues which could make a lumbar puncture unsafe:
  -  Platelets < 100,000/mm³
  -  INR > 1.1
  -  Known bleeding dyscrasia
  -  Absolute neutrophil count < 1,500/mm³
  -  Ongoing systemic bacterial infection
  PRIOR CONCURRENT THERAPY:
  -  Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following:
  -  Neurontin
  -  Lamictal
  -  Depakote, Depakene
  -  Felbatol
  -  Keppra
  -  Gabitril
  -  Topimax
  -  Zonegran
  -  No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital
  -  No concurrent other drug known to affect the metabolism of erlotinib
  -  No concurrent anticoagulant therapy

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Removal of Lung Nodules After Being Marked With a Microcoil

Summary: The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
  The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.

Detailed description: Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.

Eligibility: Inclusion Criteria:
  -  subcentimetre lung nodule
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study of XL647 Administered Orally Daily to Patients With Solid Tumors

Summary: The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Subject has histologically confirmed malignancy that is metastatic or unresectable
  -  Subject has disease that is assessable by tumor marker, physical, or radiologic means
  -  Subject is at least 18 years old
  -  Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  -  Subject has a life expectancy ≥ 3 months
  -  Subject has normal organ and marrow function
  -  Subject gives written informed consent
  -  Subject must use an accepted method of contraception during the study
  -  Female subjects of childbearing potential must have a negative pregnancy test
  Exclusion Criteria:
  -  Subject has received anticancer treatment within 30 days of first dose of XL647
  -  Subject has received another investigational agent within 30 days of first dose of XL647
  -  Subject has known brain metastases
  -  Subject has corrected QT interval (QTc) of > 0.45 seconds
  -  Subject is currently receiving anticoagulation therapy with warfarin
  -  Subject has uncontrolled intercurrent illness
  -  Subject is pregnant or breastfeeding
  -  Subject has known HIV

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Summary: This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies


Eligibility: Inclusion criteria:
  -  May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.
  -  Prior treatment with hormonal therapy is allowed.
  -  Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.
  -  Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
  -  Must be >/= 18 years of age
  -  Life expectancy of > 8 weeks
  -  Must have recovered from side effects of previous treatment
  -  Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required
  -  Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed
  -  Able to swallow and retain oral medications
  -  Must have adequate hematologic, hepatic and renal function
  Exclusion criteria:
  -  Pregnant or lactating females
  -  Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
  -  Concurrent disease or condition that would make the patient inappropriate for study participation
  -  Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment
  -  Uncontrolled infection
  -  Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient
  -  Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed
  -  History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients
  -  History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients
  -  Known DPD deficiency

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Summary: This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.


Eligibility: Inclusion criteria:
  -  Clinical labs are within acceptable ranges.
  -  A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
  -  At least 18 years of age.
  -  Females must meet certain criteria specified in protocol.
  -  Ability to swallow and retain oral medication.
  -  Ability to follow and understand directions.
  Exclusion criteria:
  -  Female who is pregnant or lactating.
  -  Medically unfit by the doctor as a result of the medical interview or physicals.
  -  Received treatment of an investigational drug within 4 weeks of study start.
  -  Currently receiving treatment with prohibited meds listed in protocol.
  -  Had major surgery in previous 2 weeks.
  -  Had prior radiation therapy to the chest to treat this incidence of breast cancer.
  -  Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
  -  Has a malabsorption syndrome.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Adrenal Function in Patients With Newly Diagnosed Lung Cancer

Summary: Patients with newly diagnosed lung cancer may have hypofunction of the adrenal cortex either from tumour metastasis or other mechanisms. Since lung cancer patient may have to undergo stressful investigation and treatments, undetected hypofunction of the adrenal cortex may be hazardous. Knowledge of the size of the problem may help determine whether routine check is warranted.


Eligibility: Inclusion Criteria:
  -  Histologically proven primary lung cancer
  -  Newly diagnosed
  -  No specific treatment given
  -  No active infection in the previous week
  -  No general anesthesia in the previous week
  Exclusion Criteria:
  -  Known adrenal disease
  -  Receiving exogenous systemic corticosteroids
  -  Concomitant illness known to affect adrenal function. e.g. active TB

Relevance to patient case: not relevant