Sorafenib in Treating Patients With Advanced Solid Tumors

Inclusion Criteria:

* Histologically or cytologically confirmed malignant solid tumor

  * Refractory disease for which curative or palliative measures have failed or for which there is no known superior treatment
  * No colorectal cancer or melanoma
* Measurable OR nonmeasurable disease
* Normotensive (blood pressure \[BP\] ≤ 140/90 mm Hg) meeting 1 of the following criteria:

  * No more than 2 attempted measurement sessions for which the documented mean systolic BP is ≤ 140 mm Hg and the diastolic BP is ≤ 90 mm Hg
  * At least 30 attempted measurement sessions for which the documented mean systolic BP is ≤ 135 mm HG and the diastolic BP is ≤ 85 mm Hg
* Brain metastases allowed provided the following criteria are met:

  * Stable neurologic status for ≥ 2 weeks after completion of definitive local therapy (surgery or radiotherapy)
  * No neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* ECOG performance status 0-1
* Life expectancy \> 12 weeks
* Age ≥ 14 years OR weight ≥ 45 kilograms (pediatric patients)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Hemoglobin ≥ 8.5 g/dL
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN (5 times ULN if there is liver involvement)
* Creatinine ≤ 1.5 times ULN
* No New York Heart Association class II-IV congestive heart failure
* No unstable angina (anginal symptoms at rest) or new-onset angina (began within the past 3 months)
* No myocardial infarction within the past 6 months
* No ventricular arrhythmias requiring anti-arrhythmic therapy
* No thrombotic or embolic events, such as symptomatic pulmonary embolus or any cerebrovascular accident (including transient ischemic attacks) within the past 6 months
* No pulmonary hemorrhage/bleeding event \> grade 2 within the past 4 weeks
* No other hemorrhage/bleeding event \> grade 3 within the past 4 weeks
* No evidence or history of bleeding diathesis or coagulopathy
* No serious nonhealing wound, ulcer, or bone fracture
* No ongoing or active infection \> grade 2
* No psychiatric illness or social situation that would limit compliance with study requirements
* No allergy to sorafenib tosylate or excipients
* No unstable condition that would jeopardize the safety of the patient and/or her/his compliance with the study
* No significant traumatic injury within the past 4 weeks
* No condition that would impair the patient's ability to swallow whole pills or capacity to absorb oral medications
* No seizure disorder requiring steroids or anticonvulsant therapy
* No other concurrent illness
* Recovered from prior therapy
* Prior vascular endothelial growth factor (VEGF) pathway inhibitor (e.g., bevacizumab, sunitinib malate, axitinib) allowed provided the following criteria are met:

  * The patient's best response as measured by RECIST criteria was not progressive disease
  * If the most recent agent was a small molecule reversible inhibitor (e.g., sunitinib malate, cediranib, or axitinib), the patient must not have taken a dose of the agent within 2 weeks of the baseline blood pressure session and 3 weeks of starting sorafenib tosylate
  * If the most recent agent was bevacizumab or VEGF trap the patient must not have received the most recent dose within 5 weeks of the baseline blood pressure session and 6 weeks of starting sorafenib tosylate AND no grade 3 bleeding, cardiovascular, skin, or thyroid toxicities on one of these previous therapies
* More than 2 weeks since prior and no concurrent radiotherapy
* At least 3 weeks since prior and no concurrent chronic epoetin alfa (or congeners)
* More than 3 weeks since prior immunotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* More than 4 weeks since prior major surgery or open biopsy
* At least 3 weeks since prior uncharacterized herbal agents or nutritional supplements
* More than 12 weeks since prior radioimmunotherapy
* No prior sorafenib tosylate
* No prior organ allograft or allogeneic bone marrow or peripheral blood stem cell transplantation

  * Patients with a history of autologous transplant and normal bone marrow function are eligible
* No prior cyclosporine, Hypericum perforatum (St. John's wort), or rifampin
* No other concurrent investigational agents
* No other concurrent antineoplastic therapy, including chemotherapy, except androgen-ablating agents (for patients with prior prostate cancer)
* No concurrent hematopoietic growth factors
* No concurrent combination antiretroviral therapy for HIV-positive or chronic hepatitis B-positive patients
* No concurrent hormonal therapy except steroids for adrenal insufficiency or hormones for nondisease-related conditions (e.g., insulin for diabetes)

  * Steroids for autoimmune cytopenia allowed provided dose has been stable for 3 weeks
* No anticipated need for other antineoplastic therapy within the next 4 weeks