Clinical trial NCT00320073 (phase 1, status: completed)
Conditions: unspecified adult solid tumor, protocol specific
ICD codes: H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: erlotinib hydrochloride, pemetrexed disodium, vinflunine
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O, CC[C@@]12C=CCN3CC[C@@]4([C@H]13)[C@@H](N(C)C1=CC(OC)=C(C=C41)[C@]1(C[C@@H]3C[C@H](C[N@@](C3)CC3=C1NC1=CC=CC=C31)C(C)(F)F)C(=O)OC)[C@](O)([C@@H]2OC(C)=O)C(=O)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed solid tumors

               -  Advanced/unresectable or metastatic disease

          -  Refractory to standard therapy OR no standard therapy exists

          -  No lymphoma

          -  Measurable or evaluable disease

               -  Measurable disease is defined as at least one target lesion measuring ≥ 20 mm by
                  conventional techniques or ≥ 10 mm by spiral CT scan

               -  Evaluable disease includes ascites, pleural effusion, bone metastases, pulmonary
                  lymphangitic spread, and lesions not meeting above criteria as measurable

                    -  Patients with clinically significant ascites or pleural effusions that
                       cannot be controlled by drainage are not eligible

          -  Brain metastases allowed if CNS-directed treatment has been given, patient has been
             off CNS-directed therapy for > 3 months, and CNS disease has been clinically and
             radiographically stable for at least 8 weeks

        PATIENT CHARACTERISTICS:

          -  Life expectancy > 3 months

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Creatinine clearance ≥ 60 mL/min

               -  Patients assigned to group 1 with creatinine clearance 45-80 mL/min must be able
                  to withhold NSAIDS during pemetrexed disodium administration

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST and ALT ≤ 3 times upper limit of normal (ULN) OR ≤ 5 times ULN if due to known
             liver metastases

          -  No New York Heart Association class III or IV heart failure

          -  No unstable angina

          -  No myocardial infarction within the past 6 months

          -  No poorly controlled hypertension

          -  No prior allergic reaction to any vinca alkaloid

          -  No uncontrolled active infection or severe illness

          -  Able to receive vitamin B12 and folate supplementation and dexamethasone during
             chemotherapy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after last
             dose of chemotherapy

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior chemotherapy, investigational agents, or surgery

          -  Concurrent cytochrome P450/CYP3A4 inducers or inhibitors are allowed provided patient
             has been on a stable dose for ≥ 2 weeks prior to study entry

          -  No concurrent ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir

          -  No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin,
             carbamazepine, phenobarbital, primidone, or oxcarbazepine) for patients assigned to
             group 2