Clinical trial NCT00454194 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pemetrexed disodium, sorafenib tosylate
SMILES: [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O, 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:

          -  Histologically or cytologically confirmed non-squamous cell non-small cell lung cancer
             (NSCLC)

               -  Stage IIIB or IV disease

               -  Squamous cell carcinomas are not allowed

                    -  Adenosquamous histology allowed

          -  Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by
             conventional techniques or ≥ 1.0 cm by spiral CT scan

               -  No nonmeasurable disease only, including small lesions and truly nonmeasurable
                  lesions, including any of the following:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Inflammatory breast disease

                    -  Lymphangitis cutis/pulmonis

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

                    -  Cystic lesions

          -  Previously treated with 1 chemotherapy regimen, including adjuvant treatment

               -  Prior treatment with adjuvant chemotherapy is allowed and not counted as a
                  regimen

          -  Symptomatic pleural effusions should be drained prior to study entry

               -  No symptomatic serosal effusion (≥ CTCAE v3.0 grade 2 dyspnea) that is not
                  amenable to drainage prior to study entry

          -  Stable brain metastasis allowed provided the following criteria are met:

               -  Treated with either whole brain radiotherapy or gamma knife surgery

               -  More than 4 weeks since prior steroids

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal

          -  Creatinine clearance ≥ 45 mL/min

          -  AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

          -  INR < 1.5 OR PT/PTT normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 2 weeks after
             completion of study treatment

          -  Able to take folic acid, cyanocobalamin, and dexamethasone

          -  No clinically significant infection

          -  No known HIV positivity

          -  No evidence or history of bleeding diathesis or coagulopathy

          -  No serious nonhealing wound, ulcer, or bone fracture

          -  No significant traumatic injury within the past 4 weeks

          -  No bleeding ≥ grade 2 (except grade 2 petechiae) within the past 4 weeks

          -  No second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous
             skin cancer, unless malignancy was diagnosed and definitively treated ≥ 5 years ago
             with no subsequent evidence of recurrence

               -  History of low-grade (Gleason score ≤ 6) localized prostate cancer allowed

               -  Patients with a history of DCIS that has been definitively treated will be
                  eligible even if diagnosed < 5 years prior to registration

          -  No other severe underlying disease or condition that, in the opinion of the
             investigator, would preclude study compliance or increase risk for serious adverse
             events

          -  Able to swallow pills

          -  No concurrent severe and/or uncontrolled medical conditions, including any of the
             following:

               -  Uncontrolled blood pressure, defined as systolic blood pressure (BP) > 150 mm Hg
                  and/or diastolic BP > 100 mm Hg, in spite of adequate antihypertensive therapy

               -  Angina pectoris

               -  Congestive heart failure within the past 3 months, unless LVEF > 40%

               -  Myocardial infarction within the past 6 months

               -  Cardiac arrhythmia

               -  Diabetes mellitus

               -  Active hemoptysis

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy, except for alopecia

          -  No prior sorafenib tosylate or pemetrexed disodium

          -  No prior therapy with agents that target VEGF, VEGF receptor, or VEGF receptor
             tyrosine kinase inhibitor (prior bevacizumab is allowed)

          -  Prior radiotherapy allowed if all the following criteria are met:

               -  No more than 25% of bone marrow was irradiated

               -  Measurable disease, whether there is in-field disease progression/recurrence or
                  disease outside the treatment fields of radiation port, is present

          -  No acetylsalicylic acid dose of ≥ 1.3 grams/day for ≥ 10 days before and after
             completion of study treatment

          -  At least 4 weeks since prior full-field radiotherapy

          -  At least 2 weeks since prior limited-field radiotherapy

          -  At least 4 weeks since prior major surgery (i.e., laparotomy) or open biopsy

          -  At least 2 weeks since prior minor surgery

          -  At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C and nitrosoureas)

          -  At least 2 weeks since prior immunotherapy, biologic therapy, or gene therapy

          -  At least 4 weeks prior hormonal therapy

          -  At least 4 weeks since other prior investigational agents

          -  No concurrent antiretroviral therapy

          -  No concurrent major surgery

          -  No concurrent steroids

          -  No concurrent therapeutic anticoagulation

               -  Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) of venous or
                  arterial access devices allowed provided requirements for PT, INR, or PTT are met

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  No concurrent grapefruit or grapefruit juice

          -  No concurrent prophylactic use of colony-stimulating factors

          -  No other concurrent anticancer agents or therapies