Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor

In brief

This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib tosylate may kill more tumor cells.

Key facts

Study ID: NCT01450384
Run by: Virginia Commonwealth University
People needed: 37
Starts: 2011-10-01
Expected to finish: 2015-09-01
Last updated by the study team: 2016-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Advanced solid tumor malignancy for which there is no potentially curative treatment; there is no limit to the number of prior lines of therapy
Performance status Eastern Cooperative Oncology Group (ECOG) equal or less than 1
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper institutional limit (ULN)
Total bilirubin =< 1.5 ULN
Creatinine clearance (CrCl) >= 45 mL/min as measured by the standard Cockcroft-Gault equation
International normalized ratio (INR) =< 1.5 (if not due to anticoagulants)
White blood cell count (WBC) >= 3,000 cells/mm3
Absolute neutrophil count (ANC) >= 1,500 cells/mm3
Platelets >= 100,000 cells/mm3
Hemoglobin (Hgb) >= 8.5 g/dL
Prior toxicities are allowed as long as they are stable and would not interfere with study drug toxicity assessment
Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) (v 1.1)
Ability to understand and the willingness to sign a written informed consent document; a signed informed consent must be obtained prior to any study specific procedures
Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment; women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation; men must agree to use a medically accepted form of birth control for 2 months following completion of study treatment

You may not qualify if…

Any investigational agent within 4 weeks of first dose of study treatment
Unwillingness or inability to take folic acid, vitamin B12, or dexamethasone
Known or presumed intolerance of pemetrexed or sorafenib; unable to swallow medication; suspected malabsorption
Active illicit substance or alcohol abuse
Contraindication to antiangiogenic agents, including:
Pulmonary hemorrhage/bleeding event >= Grade 2 within 4 weeks or less prior to the first dose of study drug
Any other hemorrhage/bleeding event >= Grade 3 within 4 weeks or less prior to the first dose of study drug
Serious non-healing wound, ulcer, or bone fracture
Thrombolic or embolic events such as a myocardial infarction, cerebrovascular accident including transient ischemic attacks within the past 6 months
Major cardiac dysfunction, such as uncontrolled angina, congestive heart failure with New York Heart Association (NYHA) class III or higher, ventricular arrhythmias requiring anti-arrhythmic therapy
Systolic blood pressure > 160 mmHg or diastolic pressure > 100 mmHg despite optimal medical management
Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5 day period
Serious uncontrolled infection > Common Terminology Criteria for Adverse Events (CTCAE) (v 4) grade 2
Peripheral motor or sensory neuropathy>CTCAE (v4) grade 2
Uncontrolled metastatic brain disease
Serum B12 or folate levels below the institution's lower limit of normal. Patients may begin B12/folic acid supplementation and can be reconsidered for study once levels meet the eligibility requirements
Administration of non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to pemetrexed dosing (note: if a candidate routinely takes NSAIDs prior to enrollment, consider transition to alternate non-NSAID for duration of study treatment, if possible).
Other condition(s) that in the opinion of the investigator might compromise the objectives of the study

Where it is running

Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.