A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

Inclusion Criteria:

Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
Be DOXIL/CAELYX treatment naïve
Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of Have an estimated life expectancy of ≥ 3 months
Be >/= 18 and Sign a written Institutional Review Board (IRB)-approved informed consent form
Have a negative pregnancy test, if patient is of child-bearing potential

Have acceptable liver function:

Bilirubin AST (SGOT), ALT (SGPT) and Alkaline phosphatase
Have acceptable renal function:

Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

Have acceptable hematologic status:

Neutrophils >/= 1500 cells/mm3
Platelet count >/= 100,000 (plt/mm3)
Hemoglobin >/= 9 g/dL

Have acceptable coagulation status:

Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
Partial thromboplastin time (PTT) within 1.5 × ULN
Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)

Exclusion Criteria:

Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days prior to Day 1
Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
Have received prior treatment with DOXIL/CAELYX
Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
Have seizure disorders requiring anticonvulsant therapy
Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)
Have severe chronic obstructive pulmonary disease with hypoxemia
Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Have received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
Have received radiation therapy to >25% of her total bone marrow during her lifetime
Are unwilling or unable to comply with procedures required in this protocol
Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Are currently receiving any other investigational agent
Have exhibited allergic reactions to doxorubicin or a similar structural compound