araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Study of Oral AEE788 in Adults With Advanced Cancer

Summary: AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid tumor
  -  Adequate hematologic, renal and hepatic function
  -  Age ≥ 18 years
  -  Karnofsky performance status score ≥ 70%
  -  Life expectancy ≥ 12 weeks
  Exclusion Criteria:
  -  Active brain metastases
  -  Peripheral neuropathy > grade 2
  -  Diarrhea > grade 1
  -  Gastrointestinal (GI) dysfunction
  -  Compromised cardiac function
  -  Concurrent severe and/or uncontrolled medical conditions

Relevance to patient case: possibly relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Study Evaluating HKI-272 in Tumors

Summary: The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.


Eligibility: Inclusion Criteria:
  -  Her2/neu or Her1/EGFR positive cancer
  -  ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
  -  Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors)
  Exclusion Criteria:
  -  Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m2
  -  Patients with significant cardiac risk factors
  -  Active central nervous system metastasis

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer

Summary: CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Detailed description: The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Eligibility: Inclusion Criteria:
  1. Pathologically proven SCC or adenocarcinoma of esophagus .
  2. Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
  3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
  4. Age ≧ 18 ys
  5. KPS ≧ 60%
  6. Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl .
  Exclusion Criteria:
  1. Invasion to surrounding organ ( T4 disease ) .
  2. Distant metastasis , except M1a disease .
  3. Patients who refuse operation .

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

Summary: To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck.
  To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.


Eligibility: Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than or equal to 6 months following the end of the prior RT.
  -  The recurrence or second primary must have defined bi- or uni-dimensional measurements.
  -  Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
  -  The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy.
  -  The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT).
  -  Patients must be at least 6 months from prior radiation therapy.
  -  Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
  -  Zubrod performance status 0-1.
  -  Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration.
  -  LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
  -  Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded.
  -  Patients must sign a study-specific informed consent form prior to study entry.
  Exclusion Criteria:- Primary in the nasopharynx or the salivary gland.
  -  Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
  -  A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study.
  -  Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.

Relevance to patient case: possibly relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: MATRIX EG (Matuzumab Treatment With ECX in Esophago-Gastric Cancer)

Summary: The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Subjects invited to take part have metastatic cancer of the esophagus (gullet) or stomach.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
  -  metastatic disease
  -  immunohistological evidence of EGFR expression from archived tissues
  -  ECOG PS 0-1
  -  at least 1 measurable lesion (modified WHO criteria)
  Exclusion Criteria:
  -  previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed > 12 months prior to study treatment
  -  radiotherapy or major surgery within 4 weeks prior to treatment
  -  brain metastases
  -  peripheral neuropathy or ototoxicity >/= Grade 2 (NCICTC V3)
  -  abnormal ECG

Relevance to patient case: definitely relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)

Summary: The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.


Eligibility: Inclusion Criteria:
  To be eligible for ACTIVE A patients must have in same time the three following conditions :
  -  Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or two ECGs recorded at two weeks a part during 6 months prior to study enrollment.
  -  Evidence of high risk of vascular events : at least one of the following risk criteria must be present :
  -  are 75 years greater;
  -  on treatment for systemic hypertension;
  -  prior stroke, Transient Ischemic Attack (TIA) or non-Central Nervous System (non-CNS) systemic embolus;
  -  left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;
  -  peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9);
  -  age 55 to 74 years and either; f1) diabetes mellitus requiring drug therapy, or f2) documented previous myocardial infarction or documented coronary artery disease.
  -  To have either a contraindication to use an oral anticoagulant treatment or they are unwilling to take an oral anticoagulant treatment.
  Exclusion Criteria:
  Patients will be excluded from ACTIVE if any of the following are present :
  -  requirement for clopidogrel (such as recent coronary stent procedure)
  -  requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
  -  prior intolerance to ASA or clopidogrel;
  -  documented peptic ulcer disease within the previous 6 months;
  -  prior intracerebral hemorrhage;
  -  significant thrombocytopenia; (platelet count < 50 x 10(9)/L)
  -  psychosocial reason making study participation impractical;
  -  geographic reason making study participation impractical;
  -  ongoing alcohol abuse;
  -  mitral stenosis,
  -  pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study; (severe comorbid condition such that the patient is not expected to survive 6 months;
  -  patient currently receiving an investigational pharmacologic agent;

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

Summary: This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.


Eligibility: Inclusion criteria:
  -  Has a histologically confirmed adenocarcinoma of the esophagus.
  -  GE (gastroesophageal) junction or gastric cardia.
  -  Must be of non-child-bearing potential or is of child-bearing potential.
  -  Have a negative serum pregnancy test and agree to an approved form of birth control.
  -  Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
  -  Have a life expectancy of at least 12 weeks.
  -  Have provided written informed consent.
  -  Investigator considers patient to be fit for study from lab test results and interview.
  Exclusion criteria:
  -  Pregnant or lactating female.
  -  Prior resection of the small bowel.
  -  Received major surgery.
  -  Received prior radiation therapy to the mediastinum or abdomen.
  -  Has a known immediate or delayed hypersensitivity reaction.
  -  Idiosyncrasy to drugs chemically related to the study drug.

Relevance to patient case: definitely relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Summary: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced/metastatic non-small cell lung cancer
  -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
  Exclusion Criteria:
  -  Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  -  History of or known brain metastases

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer

Summary: RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
  PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.
  Secondary
  -  Determine the pharmacokinetics of oxaliplatin in these patients.
  OUTLINE: This is an open-label, nonrandomized, multicenter study.
  Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity.
  Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment.
  PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal cancer
  -  Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy
  -  No pre-existing neuropathy
  -  No CNS disease or cerebral metastases
  PATIENT CHARACTERISTICS:
  -  WHO 0-1
  -  Life expectancy ≥ 12 weeks
  -  No biliary or gastro-duodenal obstruction
  -  No familial, social, geographical, or psychological condition that would preclude study treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No other concurrent drug or agent that is potentially neurotoxic

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Familial Barrett's Esophagus

Summary: This is a multi-center study whose aim is to define the epidemiology and genetics of Barrett's esophagus and adenocarcinoma. The researchers have studied families affected with Barrett's esophagus and esophageal adenocarcinoma, a specific type of cancer of the esophagus. They have found that Barrett's and esophageal cancer occur at a younger age in these families suggesting that familial Barrett's esophagus is a genetically inherited disease.

Detailed description: This research study is trying to determine whether Barrett's esophagus and associated esophageal cancers, specifically esophageal adenocarcinoma are inherited in certain families. Persons who are affected with Barrett's esophagus or esophageal cancer (adenocarcinoma type) are asked to complete a questionnaire that determines their habits and asks a detailed family history. Family members of patients seen at University Hospitals of Cleveland and the Cleveland Clinic are also being recruited for screening tests of their esophagus. The investigators plan to eventually screen family members at all participating institutions. This research will eventually lead to the identification of inherited genetic changes that cause Barrett's esophagus and esophageal cancer. It will help the investigators develop better methods for preventing or identifying esophageal cancer at an early curable stage.

Eligibility: Eligible cases will be defined as those patients and their family members who meet the following criteria:
  -  Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of the esophagus.
  -  Male or female age 18 or older at time of enrollment or male or female less than 18 years of age at time of enrollment with parental consent.
  -  Ability to give informed consent, if patient is age 18 or older.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Topical Sunscreen in Preventing Skin Rash in Patients Receiving Drugs Such as Erlotinib or Cetuximab for Cancer

Summary: RATIONALE: Topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. It is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.
  PURPOSE: This randomized phase III trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

Detailed description: OBJECTIVES:
  -  Compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo.
  -  Determine the toxicity of topical sunscreen vs placebo in these patients.
  -  Determine whether discontinuation of treatment intervention is followed by rash development.
  OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (EGFR) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients apply sunscreen generously to the entire body twice daily for 4 weeks.
  -  Arm I: Patients apply placebo generously to the entire body twice daily for 4 weeks.
  Patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks.
  After completion of study treatment, patients are followed for 8 weeks.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of cancer
  -  Receiving ≥ 1 of the following epidermal growth factor receptor (EGFR) inhibitor treatments:
  -  Gefitinib
  -  Cetuximab
  -  Erlotinib
  -  Panitumumab
  -  ICR-62
  -  Matuzumab
  -  CI-1033
  -  EGFR treatment must have begun within the past 3 days
  -  No rash (of any etiology) at study entry
  PATIENT CHARACTERISTICS:
  -  Able to apply sunscreen on face, trunk, and extremities
  -  Able to complete questionnaire(s)
  -  No history of allergic reactions or severe intolerance to sunscreen or its derivatives
  -  No history of skin problems likely to reoccur during treatment
  -  Must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No concurrent tanning bed usage
  -  No other concurrent topical sunscreens

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

Summary: The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer.
  Side effects (toxicity) information will also be collected.

Detailed description: Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery.
  Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
  Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.

Eligibility: Inclusion Criteria:
  -  Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III
  -  No prior treatment for esophageal cancer
  -  Must be surgical candidate based on stage and location of disease
  -  Measurable or evaluable disease
  -  Able to be up and perform self care
  -  Adequate liver, renal function and bone marrow function
  -  Patients will have to have a central venous access device placed
  -  Able to give written informed consent.
  -  Age 18 or older
  Exclusion Criteria:
  -  Stage IV disease
  -  Prior cancer treatment for advanced cancer in the last 5 years
  -  Pregnant or lactating women
  -  History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
  -  History of neurological disease
  -  Recent history of blood in the sputum or vomitus
  -  Non-healing wounds, ulcer or long bone fractures
  -  History of bleeding problems or coagulation problems
  -  History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
  -  History of uncontrolled hypertension
  Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Relevance to patient case: definitely relevant