araag2/HINT huggingface dataset:
Clinical trial NCT01508117 (phase 2, status: terminated)
Conditions: glioblastoma multiforme
ICD codes: L51.0, L51.8, L51.9
Drugs: axitinib
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    transferred study sponsor
  
Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed patients with histologically proven glioblastoma multiforme

          -  Age above 70 years

          -  Karnofsky score of 50-80

          -  Adequate organ function as defined by laboratory values

          -  Life expectancy of >12 weeks

          -  No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood
             pressure readings taken at least 1 hour apart. The baseline systolic blood pressure
             readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be
             90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are
             eligible.

        Exclusion Criteria:

          -  Prior treatment with chemotherapy or radiation for glioblastoma multiforme

          -  Patients with extensive tumor hemorrhage

          -  Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
             symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
             attack and 6 months for deep vein thrombosis or pulmonary embolism
Clinical trial NCT00060125 (phase 2, status: completed)
Conditions: recurrent melanoma, stage iv melanoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: tipifarnib
SMILES: CN1C=NC=C1[C@@](N)(C1=CC=C(Cl)C=C1)C1=CC2=C(C=C1)N(C)C(=O)C=C2C1=CC(Cl)=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of
             distant metastatic, non-resectable regional lymphatic, or extensive in transit
             recurrent disease

          -  Patients must have at least 2 cutaneous lesions amenable to excisional biopsy for
             correlative studies; in addition, patients must have measurable disease; the disease
             remaining after the first excisional biopsy must be measurable; lesions that are
             considered intrinsically non-measurable include the following:

               -  Bone lesions

               -  Leptomeningeal disease

               -  Ascites

               -  Pleural/pericardial effusion

               -  Lymphangitis cutis/pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

               -  Lesions that are situated in a previously irradiated area

          -  No history of brain metastases

          -  No allergies to azoles (e.g. ketoconazole) or allergies to compounds structurally
             similar to R115777

          -  No more than 1 prior immunotherapy regimen for treatment of advanced melanoma; an
             additional immunologic therapy in the adjuvant setting (e.g. IFN-a) is acceptable;
             prior chemotherapy for any stage of melanoma is not allowed

               -  No radiotherapy or immunotherapy within four weeks prior to the initiation of
                  therapy on this study

          -  CTC (ECOG) performance status 0-1

          -  Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child
             to significant risks; women and men of reproductive potential should agree to use an
             effective means of birth control; women of child-bearing age will undergo pregnancy
             testing

          -  ANC >= 1500/uL

          -  Platelets >= 100,000/uL

          -  Bilirubin =< 1.5 mg/dL

          -  Creatinine =< 2.0 mg/dL
Clinical trial NCT00408070 (phase 2, status: terminated)
Conditions: ovarian cancer, peritoneal cancer, fallopian tube cancer, stage 3 cancer, stage 4 cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02, C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: bevacizumab, carboplatin, paclitaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    did not meet accrual goals.
  
Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian
             carcinoma,

          -  stage III suboptimal surgery or biopsy,

          -  stage IV disease

          -  no prior chemotherapy

        Exclusion Criteria:

          -  unstable heart conditions

          -  high blood pressure

          -  vascular disorders

          -  bleeding problems
Clinical trial NCT00535470 (phase 2, status: completed)
Conditions: mycosis fungoides
ICD codes: C84.07, C84.00, C84.02, C84.06, C84.03, C84.08, C84.09
Drugs: 0.04% mechlorethamine gel
SMILES: CN(CCCl)CCCl
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored
             Phase II Pivotal study of MCH 0.02% in either the PG or AP formulation and have not
             achieved a complete response.

        Exclusion Criteria:

          -  Pregnant or nursing females, or males and females of childbearing potential, not using
             an effective means of contraception
Clinical trial NCT00454688 (phase 2, status: completed)
Conditions: irritable bowel syndrome
ICD codes: K58.2, K58.8, K58.0, K58.1, K58.9
Drugs: asimadoline, placebo
SMILES: CN([C@H](CN1CC[C@H](O)C1)C1=CC=CC=C1)C(=O)C(C1=CC=CC=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18-79

          -  Must sign an ICF

          -  Females of childbearing potential must have a negative pregnancy test at screening and
             must adhere to contraception throughout the trial

          -  Must have been diagnosed with IBS as a result of having at least 6 months, not
             necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal
             discomfort or pain associated with at least 2 of the following: 1)relieved with
             defecation; 2)onset associated with a change in stool frequency; 3)onset associated
             with a change in stool form

          -  Must demonstrate a willingness to comply with daily telephone diary entry

        Exclusion Criteria:

          -  Any subject with evidence of a biochemical or structural abnormality of the digestive
             tract or other co-morbid illness that might impact the ability to interpret the safety
             and efficacy data

          -  Pregnant or breastfeeding females

          -  Refusal to discontinue prohibited concomitant medications

          -  Use of an investigational drug or participation in an investigational study within 30
             days of screening

          -  Inability or unwillingness to use the touch-tone telephone data entry system
Clinical trial NCT00429494 (phase 2, status: completed)
Conditions: amenorrhea, premature ovarian failure, ovarian function insufficiency
ICD codes: N91.0, N91.1, N91.2
Drugs: leuprolide acetate
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Hematopoietic stem cell transplantation candidate.

          -  Post-menarche female less than 40 years old.

          -  Premenopausal before the start of transplantation, or the start of oral contraceptive
             pills.

          -  Follicle-stimulating hormone (FSH) less than or equal to 20 IU/L and Luteinizing
             hormone (LH) less than or equal to 20 IU/L within 1 weeks of initiation of injection
             or the ovarian status is determined by Gynecology Oncology Service.

          -  Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year
             post-transplant

        Exclusion Criteria:

          -  Breast cancer

          -  Ovarian cancer

          -  Pregnancy

          -  Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs
Clinical trial NCT01244230 (phase 2/phase 3, status: completed)
Conditions: atopic dermatitis
ICD codes: L20.89, L20.9
Drugs: fexofenadine/allegra (m016455)
SMILES: CC(C)(C(O)=O)C1=CC=C(C=C1)C(O)CCCN1CCC(CC1)C(O)(C1=CC=CC=C1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion criteria:

          -  Aged 6 months through 11 years

          -  Patients with atopic dermatitis

        Exclusion criteria:

          -  Main itching scores are 4 or less than 2 on last three consecutive days before
             registration.

          -  Patients who have itching only on face, head, or diaper area.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
Clinical trial NCT00274924 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, ifosfamide, prednisone, vincristine
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        INCLUSION CRITERIA:

          -  Diffuse large B-cell non-Hodgkin's lymphoma

               -  Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease

               -  The following lymphoma types are excluded:

                    -  Primary central nervous system lymphoma

                    -  Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear
                       presence of low-grade lymphoma on histologic sections)

                    -  Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative
                       radiotherapy is usually indicated)

                    -  Immunodeficiency-related lymphoma (i.e., after organ or bone marrow
                       transplant)

          -  Measurable disease

               -  Patient must have at least one objective measurable disease site (i.e.,
                  measurable in at least 2 perpendicular parameters)

               -  Measurable disease in the liver is required if the liver is the only site of
                  lymphoma involvement

               -  Abnormal positron emission tomography scans will not constitute evaluable
                  disease, unless verified by CT scan or other appropriate imaging

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-3

          -  For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated
             Acquisition Scan (MUGA) is required within 6 weeks prior to registration

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Creatinine < 2.0 mg/dL

          -  Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

        EXCLUSION CRITERIA:

          -  Prior chemotherapy or radiation therapy for lymphoma

          -  Prior anthracyclines or platinum compounds used as systemic chemotherapy

          -  Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow

          -  Concurrent pentostatin or trastuzumab (Herceptin®)

          -  Pregnant or nursing

          -  Prior malignancy within the past 5 years unless it was in situ OR was treated with
             curative intent AND the patient has remained relapse-free

          -  HIV positive
Clinical trial NCT00282230 (phase 2, status: terminated)
Conditions: kidney transplantation
ICD codes: N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0
Drugs: fk778
SMILES: O\C(CCC#C)=C(\C#N)C(=O)NC1=CC=C(C=C1)C(F)(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical
             living donor kidney.

          -  Patient must receive first oral dose of randomized study drug within 48 hours of
             transplant procedure.

        Exclusion Criteria:

          -  Patient has received or is receiving an organ transplant other than kidney

          -  Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.
Clinical trial NCT00363766 (phase 2, status: completed)
Conditions: non-small-cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: ly573636-sodium
SMILES: ClC1=CC(Cl)=C(C=C1)C(=O)NS(=O)(=O)C1=CC=C(Br)S1
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic non-small-cell lung cancer

          -  At least 18 years of age

          -  Have received 2 previous treatment regimens for metastatic non-small-cell lung cancer

        Exclusion Criteria:

          -  Serious pre-existing medical conditions

          -  Previous cancer (except skin cancer, excluding melanoma)

          -  Have received 3 or more previous treatment regimens for metastatic non- small-cell
             lung cancer

          -  Active treatment with Coumadin
Clinical trial NCT00525005 (phase 2, status: completed)
Conditions: stomach neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5
Drugs: dos (docetaxel, oxaliplatin and s-1)
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed gastric adenocarcinoma, initially diagnosed or recurred

          -  Unresectable, locally advanced or metastatic

          -  At least one uni-dimensional measurable lesion by RECIST criteria

          -  Age 18 to 70 years old

          -  ECOG performance status ≤2

          -  Estimated life expectancy ≥3 months

          -  Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL,
             platelets ≥100,000/µL),

          -  Adequate kidney function (creatinine <1.5 mg/dL)

          -  Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels <2 times the upper
             normal limit

          -  Written informed consent

        Exclusion Criteria:

          -  Other tumor type than adenocarcinoma

          -  Previous history of chemotherapy (exception: adjuvant chemotherapy)

          -  Presence of CNS metastasis, psychosis, or seizure

          -  Obvious bowel obstruction

          -  Evidence of serious gastrointestinal bleeding

          -  Peripheral neuropathy (NCI CTC >= Grade I)

          -  Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for
             curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

          -  Pregnant or lactating women, women of childbearing potential not employing adequate
             contraception

          -  Other serious illness or medical conditions
Clinical trial NCT00049179 (phase 2, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: cytarabine, gemtuzumab ozogamicin
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed acute myeloid leukemia (AML)

               -  FAB M1-2 or M4-7

               -  No blastic transformation of chronic myelogenous leukemia

          -  In first relapse after prior complete response

               -  Patients who relapsed after autologous or allogeneic bone marrow or peripheral
                  blood stem cell transplantation are not eligible

          -  CD33 positive

          -  Prior myelodysplastic syndromes or secondary AML allowed

          -  Concurrent enrollment on SWOG-9007 (cytogenetics protocol)

          -  No clinical or documented CNS involvement with AML

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC no greater than 30,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST or ALT no greater than 1.5 times ULN

        Renal

          -  Not specified

        Cardiovascular

          -  No unstable cardiac arrhythmias

          -  No unstable angina

        Other

          -  HIV negative

          -  No other malignancy within the past 5 years except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Carcinoma in situ of the cervix

               -  Adequately treated stage I or II cancer currently in complete remission

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

          -  No prior gemtuzumab ozogamicin for AML

        Chemotherapy

          -  Prior hydroxyurea to control high cell counts allowed

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  At least 4 weeks since prior investigational agents and recovered
Clinical trial NCT00490659 (phase 2, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gemcitabine, cisplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of NSCLC (any subtype). For
             patients entering Arm B is also allowed to confirm histopathological diagnosis of
             NSCLC intraoperatively during this trial.

          -  Node positive (clinically or pathologically) stage II disease or Stage IIIA: T1N1 or
             T2N1 or T1N2 or T2N2 or T3N1 or T3 N2, according to the revision by Mountain CF of
             American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997). For
             patient entering Arm B (with N0 stage) confirmation of N1-N2 stage must be obtained
             from intraoperative or post-surgery pathology report.

          -  Tumor amenable to curative surgical resection.

          -  Patients with clinically measurable lesions will be enrolled in this study.
             Measurability is determined according to RECIST criteria.

             • Pathological evaluation is performed after mediastinoscopy or after surgery

          -  No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular
             targeted therapy, or any other type of tumor therapy).

        Exclusion Criteria:

          -  Treatment within the last 30 days with any investigational drug.

          -  Concurrent administration of any other tumor therapy, including radiotherapy,
             cytotoxic chemotherapy, immunotherapy, molecular target therapy.

          -  Serious concomitant disorders (for example, heart failure, poorly controlled diabetes)
             at the investigator's discretion.

          -  Presence of an uncontrolled, active infection requiring therapy (at the discretion of
             investigator.).

          -  Stage IIIb or IV.
Clinical trial NCT01489046 (phase 2, status: terminated)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: bms-986001, bms-986001, bms-986001, placebo matching with bms-986001, efavirenz, lamivudine, tenofovir
SMILES: CC1=CN([C@@H]2O[C@](CO)(C=C2)C#C)C(=O)NC1=O, CC1=CN([C@@H]2O[C@](CO)(C=C2)C#C)C(=O)NC1=O, CC1=CN([C@@H]2O[C@](CO)(C=C2)C#C)C(=O)NC1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O, C[C@H](CN1C=NC2=C1N=CN=C2N)OCP(O)(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age, (or minimum age as determined by local regulatory or as
             legal requirements dictate, whichever is higher)

          -  Plasma HIV-1 RNA > 5000 copies/mL

          -  Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week
             of an antiretroviral drug

          -  CD4+ T-cell count > 200 cells/mm3

        Exclusion Criteria:

          -  Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF),
             Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)

          -  Contraindications to any of the study drugs
Clinical trial NCT01222676 (phase 2, status: unknown status)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: cisplatin, gemcitabine hydrochloride, sorafenib tosylate
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Confirmed transitional cell carcinoma (TCC) of the bladder at the time of diagnostic
             transurethral resection of the bladder tumor (TURB)*

               -  Muscle-invasive (T ≥ 2) disease at TURB OR clinical stage T3 or T4 disease (e.g.,
                  T2 patients will not be eligible without a histological documentation of invasive
                  disease)

          -  NOTE: *Confirmation of TCC histology based on pathologic review at Fondazione Istituto
             Nazionale dei Tumori Milan will be required in all cases.

          -  Clinically node-negative (cN0) disease

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  WBC ≥ 2,000/µL

          -  ANC ≥ 1,500/µL

          -  Platelet count ≥ 100,000/µL

          -  Serum creatinine ≤ 1.5 mg/dL

          -  AST/ALT < 2.5 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic
             metastases)

          -  Total bilirubin < 1.5 times ULN

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Negative serology for the following infectious diseases:

               -  HIV type 1 or 2

               -  Hepatitis B surface antigen (active carriers)

               -  Hepatitis C

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic therapies except for intravesical therapy for superficial disease

          -  No prior sorafenib tosylate

          -  No prior systemic chemotherapy

          -  At least 4 weeks since prior investigational agents