Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

Inclusion Criteria:

* Signed and dated written informed consent.
* Subjects ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Current diagnosis of any stage I to III malignant solid tumor at high risk of metastatic recurrence (deemed by treating physician as patients with ≥ 50% chance of cancer metastatic recurrence within 5 years of diagnosis)
* Patients must have completed all standard locoregional and systemic therapy for their cancer within 120 days of study enrollment.
* Administration of an investigational agent prior to enrollment needs to be completed at least 30 days prior to enrollment
* Patients must have recovered (≤ grade 1 toxicities or grade 2 toxicities well managed with optimal medical care) from effects of local (surgery, radiation) or systemic treatments.
* Platelet count ≥ 100,000 per mL of blood
* Hemoglobin ≥ 9/g/dL (may have been transfused)
* Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation
* Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN
* INR below upper limit of normal (ULN)
* Female patients of childbearing potential and non-sterile males must agree to use at least two methods of acceptable contraception from 15 days prior to first trial treatment administration until at least 5 months after study participant's final dose of study drug

Note: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women. Non-sterile males are those who have not had a vasectomy with documentation of the absence of sperm in the ejaculate.

* Patients unable to read/write in English are eligible to participate in the overall study but will not participate in the Patient-Reported Outcome questionnaires throughout the trial.
* Re-enrollment of a subject that has discontinued the study as a pre-treatment screen failure (i.e. a consented patient who did not receive study drugs) is permitted. If reenrolled, the subject must be re-consented. Only the screening procedures performed outside of protocol-specified timing must be repeated.

Exclusion Criteria:

* Evidence of biopsy-proven distant metastatic disease after completion of standard treatment
* Current use of anti-platelet drugs (ASA, NSAIDs, clopidogrel, argatroban, etc.) or anticoagulants (warfarin, heparin products, etc.)
* Active malignancy within 5 years prior to current diagnosis except for in situ disease or cancer with very high curability rate (i.e. testicular cancer, etc.)
* Uncontrolled co-morbid serious systemic illnesses that in the opinion of the investigator could compromise therapeutic safety.
* No concurrent anticancer therapy. Required washout from prior therapy:

  * Chemotherapy: 21 days
  * Major surgery: 14 days (provided wound healing is adequate)
  * Radiation: 7 days
  * Investigational/Biologic Therapy: 30 days
* Current symptomatic congestive heart failure (New York Heart Association \> class II), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic \> 160 mmHg or diastolic \> 100mmHg). Or any of the following occurring within 6 months (180 days) prior to first dose of study drugs: Myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack. (Use of antihypertensive medication to control blood pressure is allowed.)
* Ongoing peptic ulcer disease requiring treatment
* History of gastrointestinal bleed
* Severe gastro-esophageal reflux disease requiring treatment
* History of bleeding diathesis
* Pregnant or breastfeeding females.
* Prisoners or subjects who are involuntarily incarcerated.
* Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient's study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.