• Maximum tolerated dose of sorafenib tosylate [ Designated as safety issue: Yes ]
  
• Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  
• Disease response as assessed by RECIST criteria [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• To determine the maximum tolerated dose of sorafenib tosylate when given in combination with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid tumor malignancy including, but not limited to, breast, lung, colon, pancreatic, prostate, or head and neck cancer or sarcoma.

Secondary

• To characterize the quantitative and qualitative toxicities of this regimen in these patients.
• To obtain preliminary information about the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of sorafenib tosylate.

Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2 hours and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days, every 8 weeks until disease progression, and then every 3 months for up to 6 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-hematologic malignancy including, but not limited to, any of the following:

  • Breast cancer
  • Lung cancer
  • Colon cancer
  • Pancreatic cancer
  • Prostate cancer
  • Head and neck cancer
  • Sarcoma
• No squamous cell lung cancer

• Advanced disease

  • Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy

    • Patients with mesothelioma do not have to meet prior therapy requirements in order to be enrolled on the study since the combination of cisplatin and pemetrexed disodium is considered current standard first-line therapy for mesothelioma
• Measurable or nonmeasurable disease as defined by RECIST criteria
• Previously treated stable brain metastases allowed

• No clinically significant third-space fluid, such as pleural effusion or ascites

  • Third-space fluid allowed provided it can be completely drained
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• ECOG performance status 0-2
• ANC ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Hemoglobin ≥ 9 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
• AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
• Serum creatinine ≤ 1.5 mg/dL
• Creatinine clearance > 45 mL/min
• INR < 1.5 OR PT/PTT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 2 weeks after completion of study treatment
• Able to take folic acid and vitamin B_12
• Able to take oral medications without crushing, dissolving, or chewing tablets
• No malabsorption problem
• No other condition that impairs the patient's ability to swallow whole pills
• No New York Heart Association class III-IV congestive heart failure
• No unstable angina (anginal symptoms at rest) or new onset angina within the past 3 months
• No myocardial infarction within the past 6 months
• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
• No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
• No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
• No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
• No evidence or history of bleeding diathesis or coagulopathy
• No known or suspected allergy to sorafenib tosylate, pemetrexed disodium, cisplatin, or any agent given in the course of this study
• No known HIV infection or chronic hepatitis B or C infection
• No active clinically serious infection > CTCAE grade 2
• No serious nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 4 weeks
• No peripheral neuropathy ≥ CTCAE grade 2
• No second primary malignancy except in situ carcinoma of the cervix or breast or other in situ malignancies, adequately treated basal cell carcinoma of the skin, or other malignancy treated at least 3 years ago with no evidence of recurrence

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since prior systemic therapy (6 weeks for bevacizumab) and recovered
• At least 3 months since prior pemetrexed disodium or cisplatin
• No prior sorafenib tosylate
• More than 4 weeks since prior major surgery or open biopsy

• No NSAIDs or salicylates for 2 days before, during, and for 2 days after pemetrexed disodium administration

  • No NSAIDs or salicylates with a long half-life (e.g., naproxen, piroxicam, diflunisal, albumetone) for 5 days before, during, and for 2 days after pemetrexed disodium administration
• No concurrent Hypericum perforatum (St. John's wort) or rifampin
• Concurrent anti-coagulation treatment with warfarin or heparin allowed