araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in treating patients who have advanced or metastatic cancer of the pancreas.

Detailed description: OBJECTIVES: I. Determine the 6-month and overall survival rates in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with gemcitabine and ISIS 2503. II. Determine the response rate of these patients treated with this regimen. III. Assess the toxicity of this regimen in this patient population.
  OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and ISIS 2503 IV continuously on days 1-14. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to standard curative therapy Duct cell Undifferentiated The following cellular types are not eligible: Islet cell carcinoma Acinar cell carcinoma Cystadenocarcinoma No CNS metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No underlying disease associated with active bleeding Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no greater than 3 times ULN PT and PTT normal Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study
  PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy No concurrent immunotherapy No colony-stimulating factors during first course of therapy Chemotherapy: No prior chemotherapy except radiosensitizing agents used in adjuvant setting or in treatment of locally advanced disease No prior gemcitabine No prior ISIS 2503 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 25% or greater of bone marrow No concurrent radiotherapy Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in treating patients who have locally advanced pancreatic cancer.

Detailed description: OBJECTIVES: I. Determine the safety and surgical feasibility of electroporation therapy with bleomycin in patients with locally advanced pancreatic cancer. II. Determine the overall and progression-free survival of patients treated with this regimen.
  OUTLINE: Patients receive bleomycin intratumorally during laparotomy. Approximately 15 minutes after the intratumoral injection, patients receive bleomycin IV over 10 minutes. Approximately 5 minutes after the IV injection, patients undergo electroporation therapy comprising electrical pulses directly to the pancreas and surrounding tissues. Patients are followed weekly for 4-6 weeks and then every 2 months thereafter.
  PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12-18 months.

Eligibility: DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the pancreas Unresectable disease by exploratory laparotomy Involvement of the superior mesenteric artery or occlusion of the superior mesenteric vein-portal vein confluence No extrapancreatic metastases by ultrasound, CT scan, or laparotomy Tumor must be accessible for direct injection of study drug and placement of electrode array
  PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT no greater than 3 times upper limit of normal No impaired hepatic function Renal: Creatinine no greater than 1.5 mg/dL No impaired renal function Cardiovascular: No impaired cardiac function Pulmonary: No compromised pulmonary function No pulmonary condition that would potentially require the use of high FIO2 levels Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior reaction to bleomycin No fever, infection, or other medical condition that would preclude study Not at high risk for complications associated with abdominal surgery
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior lifetime cumulative dose of bleomycin greater than 400 U Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Summary: Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.


Eligibility: Inclusion Criteria:
  -  Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body.
  -  You must have one tumor that can be physically measured or scanned by the doctor.
  -  You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU.
  -  You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis.
  Exclusion Criteria:
  -  Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study.
  -  Documentation that the cancer has spread to your brain.
  -  Pregnant or breastfeeding.
  -  A second primary cancer.
  -  Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas

Summary: The goal is to assess survival and patterns of failure in patients treated with Gemzar-based chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.


Eligibility: Patients must have cytologic or histologic proof of adenocarcinoma of the pancreas.
  All patients must be staged with a physical exam and CXR. Patients must have locally advanced disease defined as tumor extension to the celiac axis or SMA, or occlusion of the SMPV confluence (on contrast-enhanced CT). There must be no radiographic evidence of metastatic disease.
  Patients must have had no prior chemotherapy or irradiation.
  Patients must have a baseline Karnofsky performance status of at least 60.
  Patients must have adequate bone marrow reserve platelet count >100,000/mL, hemoglobin>9 g/dL, absolute granulocyte count must be >1,500 cells/mm3,serum creatinine must be <1.6 mg/dL. Serum bilirubin must be less than 5 mg/dL prior to therapy with endoscopic or percutaneous drainage if necessary.
  Patients must have estimated life expectancy of at least 12 weeks.
  Patients must be at least 18 years of age. There will be no upper age restriction.
  Female patients must have had childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, barrier device, or abstinence.
  Patients cannot have hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.
  Before receiving external beam irradiation, patients should be able to maintain adequate oral nutrition (90% to 100% of estimated need of calories and protein) and be free of significant nausea and vomiting.
  Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or >2/3 of one functioning kidney must be able to be shielded from the radiation beam.
  Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
  Patients must sign an informed consent form

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies

Summary: This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Detailed description: Phase I Primary Objective:
  -  Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.
  Phase II Primary Objective:
  -  Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.
  Phase II Secondary Objective:
  -  Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Eligibility: Inclusion Criteria
  -  Pancreatic cancer (AJCC Stage II-IV);
  -  Unresectable cancer;
  -  Measurable disease (RECIST criteria);
  -  No prior therapy;
  -  ECOG Score 0-2
  -  Life expectancy greater then or equal to three months;
  -  Adequate hematopoietic, liver and renal function;
  -  Women of child-bearing potential must have negative urine/serum pregnancy test;
  -  Signed written informed consent;
  -  Subjects must be willing to be followed during the course of the treatment/observation and follow-up.
  Exclusion Criteria:
  -  Prior therapy for pancreatic cancer;
  -  Previously diagnosed brain metastases if symptomatic and requiring active therapy;
  -  Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
  -  Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study
  -  Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication;
  -  Women must not be pregnant or breast-feeding;
  -  Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

Summary: The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.

Detailed description: This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are:
  Primary Objective:
  -  Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine.
  Secondary Objectives:
  -  Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine
  -  Further characterize the safety of ARQ 501 in combination with gemcitabine

Eligibility: Inclusion Criteria:
  -  Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
  -  Be treatment-naïve.
  -  Have measurable disease per RECIST Criteria.
  -  Be ≥18 years old.
  -  Have a Karnofsky Performance Status (KPS) of ≥70%.
  -  Have an estimated life expectancy of ≥12 weeks.
  -  Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
  -  Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
  -  Sign a written informed consent form.
  -  Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.
  Exclusion Criteria:
  -  Have received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
  -  Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
  -  Are pregnant or lactating.
  -  Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
  -  Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  -  Have symptomatic or untreated central nervous system (CNS) metastases.
  -  Have a known hypersensitivity to gemcitabine.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Summary: The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.


Eligibility: Inclusion Criteria:
  -  Men or women age ≥18 years
  -  Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
  -  Measurable disease defined per RECIST
  -  Karnofsky Performance Status ≥50
  -  Expected survival ≥12 weeks
  -  Provide written informed consent
  Exclusion Criteria:
  -  CNS metastases
  -  Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
  -  Radiation therapy to >25% of the bone marrow
  -  Clinically significant laboratory abnormalities
  -  Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
  -  The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents
  -  Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
  -  Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
  -  Pregnancy or lactation

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb
  -  Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2.
  -  Patients may have to have tumor biopsy before and after treatment.
  Exclusion Criteria:
  -  Prior stem cell or bone marrow transplant
  -  Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
  -  Active or unstable cardiac disease or history of heart attack within 6 months

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase 1 Study Of An Intravenously Administered Cyclin-Dependent Kinase Inhibitor In Patients With Advanced Cancer

Summary: AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors). This research study is the first time that AG-024322 will be given to people.

Detailed description: The study was prematurely discontinued due to the inability of the compound to adequately differentiate from other treatment options in the clinical endpoint and necessary product profile on April 13, 2007. Safety profile was not the reason that led to the discontinuation of the program.

Eligibility: Inclusion Criteria:
  -  Advanced solid tumors or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition
  -  Adequate blood cell counts, kidney function and liver function and and ECOG score of 0 or 1.
  Exclusion Criteria:
  -  Prior high-dose chemotherapy requiring hemapoietic stem cell rescue
  -  Previous radiation therapy to >25% of the bone marrow
  -  Active or unstable cardiac disease or history of heart attack within 6 months

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

Summary: Pancreatic cancer has traditionally been treated with chemotherapy and radiation therapy with limited results. Preliminary studies of parts of this program in patients with advanced pancreatic cancer have produced favorable results with acceptable side effects. We feel that this treatment sequence may help to slow and/or control the growth of pancreatic cancer.
  This study will help doctors learn whether pancreatic cancer will respond to this treatment. This study will use the combination of two chemotherapy drugs, gemcitabine and cisplatin, before and after treatment with radiation therapy and an oral chemotherapy drug called capecitabine. This sequence of combination chemotherapy before and after radiation therapy, and radiation therapy with the drug capecitabine is what is under study. Parts of this sequence, for example, the combination of gemcitabine and cisplatin, have shown promising results in the treatment of pancreatic cancer. This research study is an attempt to combine these various parts.


Eligibility: Eligibility Criteria
  1. Patients must have cytologic or histologic confirmation of pancreatic carcinoma.
  2. Patients must have unresectable disease with or without distant metastases. A status of unresectable will be based on review of helical CT scan and surgical consultation.
  3. Patients with a history of previous abdominal irradiation or chemotherapy for pancreatic cancer are ineligible.
  4. Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of ≤ 2 (appendix I).
  5. Patients must be 18 years of age or older. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.
  6. Patients must have adequate organ function defined as follows: bone marrow - granulocytes ≥ 1500/cmm, platelets > 100,000/cmm, renal - serum Cre < 1.5 mg/dl, hepatic - bilirubin < 3 mg/dl.
  7. Patients must be free of other active systemic malignancy or any other serious co-morbid medical or psychiatric condition that would interfere with safe delivery of protocol therapy.
  8. Patients must be aware of the investigational nature of the therapy and provide written informed consent as per institutional guidelines prior to the initiation of treatment.

Relevance to patient case: not relevant