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

1. Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX

2. Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.

3. Be DOXIL/CAELYX treatment naïve

4. Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.

5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2

6. Have an estimated life expectancy of ≥ 3 months

7. Be >/= 18 and </= 70 years of age

8. Sign a written Institutional Review Board (IRB)-approved informed consent form

9. Have a negative pregnancy test, if patient is of child-bearing potential

10. Have acceptable liver function:

11. Have acceptable renal function:

12. Have acceptable hematologic status:

13. Have acceptable coagulation status:

14. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)

1. 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

2. Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds

3. Have received prior treatment with DOXIL/CAELYX

4. Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents

5. Have seizure disorders requiring anticonvulsant therapy

6. Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)

7. Have severe chronic obstructive pulmonary disease with hypoxemia

8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1

9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy

10. 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.

11. 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).

12. Have received radiation therapy to >25% of her total bone marrow during her lifetime

13. Are unwilling or unable to comply with procedures required in this protocol

14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

15. 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

16. Are currently receiving any other investigational agent

17. Have exhibited allergic reactions to doxorubicin or a similar structural compound