araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary: The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
  -  Recurrent and/or metastatic SCCHN, not suitable for local therapy.
  -  At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
  -  Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.
  Exclusion Criteria:
  -  Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
  -  Nasopharyngeal carcinoma.
  -  Medical history of diagnosed interstitial lung disease.
  -  Known hypersensitivity against any of the components of the trial treatment.
  -  Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
  -  Relevant cardiovascular co-morbidities.
  -  Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
  -  Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

Summary: To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

Detailed description: To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer.
  To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.

Eligibility: Inclusion Criteria:
  -  Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
  -  Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
  -  Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
  -  The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
  -  Patients must be 20 years of age and 75 years of age.
  -  Patients must have an ECOG performance status score 2.
  -  Patient's hematologic function, liver function and renal function must meet the eligibility requirements.
  -  Patients must sign the informed consent.
  Exclusion Criteria:
  -  Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
  -  Patients with brain metastases.
  -  Patients with bone metastases only.
  -  Patients with pregnancy or breast-feeding.
  -  Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
  -  Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion.
  -  Patients who are receiving other anticancer cancer drug(s) for SCCHN.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

Summary: The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.
  Symphogen was the sponsor for planning/conducting and reporting results for this trial.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
  -  Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
  -  Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
  -  Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
  -  Documented disease progression (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
  -  Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
  -  Other protocol-defined inclusion criteria could apply
  Exclusion Criteria:
  -  More than 2 lines of prior chemotherapy in the palliative setting
  -  Expected survival <12 weeks
  -  Subjects with known brain metastases
  -  Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
  -  Anti-EGFR mAbs within 14 days prior to Visit 2
  -  Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery
  -  Other protocol-defined exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma

Summary: Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed squamous cell carcinoma of head and neck
  -  Age ≥ 18
  -  ECOG PS 0-2
  -  Documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab
  -  At least one bidimensionally measurable disease
  -  Adequate organ function for treatment
  -  Availability of tumor tissue for molecular analysis (archival or rebiopsy tissue)
  Exclusion Criteria:
  -  Nasopharyngeal carcinoma
  -  Eligibility for local therapy (surgery or radiotherapy)
  -  Previous treatment with small molecule EGFR tyrosine kinase inhibitors
  -  More than one systemic chemotherapy
  -  Any major operation or irradiation within 4 weeks of baseline disease assessment
  -  Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  -  CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
  -  Patients with known interstitial lung disease
  -  Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
  -  Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
  -  Pregnant or breast-feeding women
  -  Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Summary: Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Detailed description: Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
  SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.

Eligibility: Inclusion Criteria:
  -  Adult male and female subjects, 19-80 years of age;
  -  Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
  -  Voluntarily consent to participate in the study
  -  Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
  -  IUD in place for at least 3 months prior to study;
  -  Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
  -  Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
  -  Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
  -  Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).
  Exclusion Criteria:
  -  Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
  -  History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
  -  Presence of alcoholism or drug abuse
  -  Participation in another investigational drug or device clinical trial within 30 days prior to the study
  -  Female subjects who are pregnant or lactating

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.

Detailed description: OBJECTIVES:
  Primary
  -  Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers.
  Secondary
  -  Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm.
  OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with PTEN antibody and analyzed with AQUA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Treated on protocol ECOG-E5397
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Biomarkers in Patients With Head and Neck Cancer

Summary: RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
  -  To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.
  OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.

Eligibility: DISEASE CHARACTERISTICS:
  -  Treated on protocol ECOG-E5397
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Summary: Collection of tissues for analysis from patients undergoing elective neck dissection.
  The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.

Detailed description: The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.
  The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.

Eligibility: Inclusion Criteria:
  -  All patients with biochemical evidence of squamous cell carcinoma of the head and neck.
  Exclusion Criteria:
  -  Patients without biomedical evidence of squamous cell carcinoma.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.

Detailed description: OBJECTIVES:
  -  To investigate the association between biomarkers (HPV tumor status and ERCC1 expression) and clinical outcomes in a population of patients with recurrent or metastatic head and neck cancer.
  -  To develop the ability to select patients likely to respond to therapy and to avoid treatment with ineffective therapies, especially since these therapies have substantial toxicity.
  -  To estimate response and survival rates of HPV-negative and -positive patients in each study. (exploratory)
  OUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC analysis.
  Samples are classified into two categories based on their biomarker status: HPV tumor status (negative versus positive), and ERCC1 expression level (low versus high).

Eligibility: DISEASE CHARACTERISTICS:
  -  Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301
  -  Stage III, IV, or recurrent disease
  -  Squamous cell disease
  -  Any of the following diagnoses:
  -  Lip and oral cavity
  -  Oropharynx
  -  Hypopharynx
  -  Larynx
  -  Paranasal sinus and nasal cavity
  -  Squamous neck cancer
  -  Salivary gland
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

Summary: Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.


Eligibility: Inclusion Criteria:
  -  preoperative diagnosis of head and neck squamous cell carcinoma
  -  surgery as initial treatment
  Exclusion Criteria:
  -  cases in which the ND specimen could not be separated from the primary tumor
  -  past history of neck surgery

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

Summary: This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer


Eligibility: Inclusion criteria:
  -  Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
  -  Site of disease that can be safely biopsied
  Exclusion criteria:
  -  Patients received prior anti-HER3 antibody treatment
  -  Patients with impaired cardiac function
  -  Brain metastases that have not been adequately treated
  -  Malignant disease other than that being treated in this study
  -  Pregnant or nursing (lactating) women
  -  Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Studying Biomarkers in Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1302 Trial

Summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This laboratory study is looking at biomarkers in samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.

Detailed description: OBJECTIVES:
  -  To evaluate the frequency of ATP-binding cassette, sub-family G (WHITE), member 2 (ABCG2), met proto-oncogene (hepatocyte growth factor receptor) (c-MET), and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) polymorphisms or mutations in this study population and the predictiveness of these polymorphisms on survival, time to progression, response rate, and toxicities.
  OUTLINE: Archived tumor tissue and peripheral blood mononuclear cells are analyzed for the frequency of ABCG2, c-MET, and K-ras polymorphisms or mutations by polymerase chain reaction (PCR). Results are then correlated with patients' clinical outcomes and toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients diagnosed with recurrent or metastatic head and neck cancer treated on Eastern Cooperative Oncology Group (ECOG)-E1302 trial
  -  Patients treated with docetaxel with versus without gefitinib
  -  Existing paraffin blocks and peripheral blood mononuclear cells
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant