Eribulin Mesylate and Cyclophosphamide in Treating Patients with Solid Tumors

Inclusion Criteria

• Phase Ib: Patient must have histologically or cytologically documented solid tumor malignancies
• Phase II: Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic carcinoma of the breast
• Patient must have performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale and life expectancy > 3 months
• Patients with =< grade 1 peripheral neuropathy are eligible for this trial using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, regardless of use of therapy for neuropathy including gabapentin
• Patient must have evaluable disease; measurable disease is not required
• Absolute neutrophil count (ANC) >= 1,000/uL
• Platelets >= 100,000/uL
• Hemoglobin >= 9 g/dL
• Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min for patients with creatinine levels > 1.5 x institutional ULN * Creatinine clearance should be calculated per institutional standard
• Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 x ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3 x ULN or =< 5 x ULN in patients with known liver metastasis
• Potassium in normal range * Patients with hypokalemia at screening must be corrected prior to initiating treatment
• Female patient of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to receiving the first dose of study medication and agree to the use of effective methods of contraception while on study
• Any number of prior lines of chemotherapy in the metastatic setting is allowed
• Concomitant use of bisphosphonates is allowed
• Patients with stable and clinically insignificant central nervous system (CNS) disease are allowed; patients must be off steroids with no new CNS symptoms or findings on radiographic imaging for 1 month
• Patients willing and able to complete the questionnaires
• Patients willing and able to comply with the study protocol for the duration of the study
• Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice

Exclusion Criteria

• Patients who have had chemotherapy or radiotherapy within two weeks, 4 weeks for nitrosoureas, mitomycin C, pegylated-doxorubicin and one half-life for bevacizumab, hormone therapy within one week, trastuzumab within 2 weeks or lapatinib within one week of study day 1
• If the patient has residual toxicity from prior treatment, toxicity must be =< grade 1
• Patients with non-healing surgical wounds; patients must be at least two weeks from a major surgical procedure, and surgical wounds must be completely healed
• Patients with known active CNS metastases and/or carcinomatous meningitis; however, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: * No evidence of new or enlarging CNS metastasis * Off steroids that are used to minimize surrounding brain edema; patients with clinically insignificant brain metastases that do not require treatment are eligible
• Patients with known hypersensitivity to the components of study drug or its analogs
• Congestive heart failure, clinically significant cardiac arrhythmia, history or current evidence of a myocardial infarction during the last 6 months, and/or a current electrocardiogram (ECG) tracing that is abnormal in the opinion of the treating Investigator, or unstable angina
• Corrected QT (QTc) prolongation > 480 msec (Bazett's formula) or congenitally long QT syndrome
• Severe/uncontrolled concurrent illness/infection
• Patients with other active, current primary malignancies, other than carcinoma in situ of the cervix or non-melanoma skin cancer
• Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
• Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
• Patients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the study