A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer

Inclusion Criteria:

To qualify for randomization and treatment the following criteria must be met:

- Subjects must sign an approved informed consent form

- Subjects must be ≥ 18 years of age

- Subjects must have pathology-confirmed epithelial ovarian, fallopian tube, or primary
peritoneal carcinoma

- Subjects must have platinum-resistant ovarian cancer, where platinum-resistant is
defined as disease that responded to primary platinum therapy and then progressed
within 6 months or disease that progressed during or within 6 months of completing
secondary platinum therapy

- Subjects must have at least a single (RECIST-defined) measurable lesion on a
radiological evaluation that is conducted no more than four weeks prior to beginning
study therapy (EC145 and/or PLD).

- Subjects must have had prior debulking surgery

- Subjects must have received prior platinum-based chemotherapy but must not have
received more than 2 prior systemic cytotoxic regimens. Subjects are allowed to
receive, but are not required to receive, one additional non-cytotoxic regimen for
the management of recurrent or persistent disease. Non-cytotoxic (biologic or
cytostatic) agents include, but are not limited to, monoclonal antibodies, cytokines,
and small-molecule inhibitors of signal transduction.

- Subjects must have an ECOG performance status of 0 to 2

- Subjects must have recovered (to baseline/stabilization) from prior cytotoxic
therapy-associated acute toxicities. Subjects who have recovered from non-cytotoxic
therapy-associated toxicity or who have "controlled" non-cytotoxic therapy toxicity
(e.g., vascular endothelial growth factor-related hypertension) can be entered into
the trial after a drug wash-out period of 4 half lives

- Subjects must have adequate organ function including:

1. Bone Marrow Reserve: Absolute neutrophil count(ANC)≥ 1.5x10^9/L prior to
treatment. Subjects on maintenance doses of G-CSF are eligible. Platelets ≥
100x10^9/L and hemoglobin ≥ 9 g/dL.

2. Hepatic: Total bilirubin level < 1.5 x ULN and alanine aminotransferase (ALT),
aspartate aminotransferase (AST), gamma glutamyl transferase(GGT), and alkaline
phosphatase levels < 2.5 x ULN.

3. Renal: Serum creatinine level ≤ 1.5 x ULN or creatinine clearance ≥ 50
mL/min/1.73m^2 for subjects with serum creatinine levels above 1.5 x ULN.

4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the
institutional lower limit of normal. LVEF must be elevated within 90 days prior
to C1D1.

- Subjects of childbearing potential must:

1. Have a negative serum pregnancy test prior to initiation of the therapeutic
regimen

2. Practice an effective method of birth control (e.g., oral, transdermal or
injectable contraceptives, intrauterine device, double-barrier contraception,
such as diaphragm and spermicidal jelly) for the duration of their participation
in the trial through 3 months following the last dose of study drug.

Exclusion Criteria:

The presence of any of the following will exclude the subject from the study:

- Diagnosis of tumor of low-malignant potential

- Prior exposure to PLD or anthracycline therapy

- Prior exposure to FR-targeted therapy (EC145, EC0225, farletuzumab, etc)

- Prior therapy with mouse antibodies

- Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds

- Prior abdominal or pelvic radiation therapy, radiation therapy to > 10% of the bone
marrow, or prior radiation therapy within the past 3 years to the breast/sternum,
dermal lesions, head or neck

- Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis

- Serious comorbidities (as determined by the investigator) such as, but not limited
to, active congestive heart failure or recent myocardial infarction. Subjects who
require antifolate therapy for the management of comorbid conditions (e.g.,
rheumatoid arthritis) will be excluded from the trial.

- Pregnancy

- Concurrent malignancy or history of other cancer (except noninvasive skin cancer)
within the last 5 years

- Symptomatic central nervous system metastasis

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
that is considered to be investigational (i.e., used for non-approved indications(s)
and in the context of a research investigation). Use of low dose corticosteroid
therapy (for nausea prophylaxis, etc) is acceptable; however, concomitant tamoxifen
therapy is not. Supportive care measures are allowed.