Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer

Inclusion Criteria:

- The patient has histologically or cytologically confirmed epithelial ovarian cancer,
primary peritoneal carcinoma, fallopian tube cancer, or ovarian clear cell carcinoma

- The patient must have at least one of the following: a platinum-free interval of ≤ 12
months after the final dose of primary or subsequent platinum-based therapy
(platinum-resistant), progression during primary or subsequent Platinum-based therapy
(platinum-refractory), or persistent radiographic disease after primary or subsequent
platinum-based therapy (platinum-refractory)

- The patient has a pre-study echocardiogram or multigated acquisition (MUGA) scan with
an actual left ventricular ejection fraction (LVEF) ≥ 50%, within 21 days prior to
randomization

- The patient has at least one unidimensionally measurable target lesion (≥ 20 mm with
conventional techniques, or ≥ 10 mm by spiral computed tomography [CT] or magnetic
resonance imaging [MRI]), as defined by Response Evaluation Criteria in Solid Tumors,
Version 1.0 (RECIST v 1.0) guidelines. Tumors within a previously irradiated field
will be designated as "nontarget" lesions unless progression is documented or a
biopsy is obtained to confirm persistence at least 90 days following completion of
radiation therapy

- The patient has recovered to Grade ≤ 1 by the National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the
effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other
targeted therapies for ovarian cancer, with the exception of alopecia or peripheral
neuropathy (which must have resolved to Grade ≤ 2). The exceptions for such effects
are allowed lab values of ≤ Grade 2 specified elsewhere in these inclusion criteria

- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status score
of ≤ 1 at study entry

- The patient has the ability to understand and the willingness to sign a written
informed consent

- The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥
1200 cells/μL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000 cells/μL)

- The patient has adequate hepatic function as defined by total bilirubin ≤ 1.5 × the
upper limit of normal (ULN), and aspartate transaminase (AST) and alanine
transaminase (ALT) ≤ 3 × the ULN (or ≤ 5 × the ULN in the presence of known liver
metastases)

- The patient has adequate renal function as defined by serum creatinine ≤ 1.5 × the
institutional ULN. If creatinine is above the ULN, the patient's creatinine clearance
is ≥ 60 mL/min

- The patient has urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine
dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate <
1000 mg of protein to allow participation

- The patient must have adequate coagulation function as defined by International
Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds
above ULN. Patients on anticoagulation must be on a stable dose of anticoagulant with
a therapeutic INR and no active bleeding within 14 days prior to randomization, or on
low molecular weight heparin AND have no pathological condition carrying a high risk
of bleeding. Mild elevations of PTT of up to 1.5 × the ULN are acceptable, provided
that, in the opinion of the investigator, they are related to ongoing use of
coumarins (eg, warfarin)

- The patient has a pre-study echocardiogram or multigated acquisition (MUGA) scan with
an actual left ventricular ejection fraction (LVEF) ≥ 50%, within 21 days prior to
randomization

- women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to randomization and for the
duration of study participation

Exclusion Criteria:

- The patient has brain metastases or leptomeningeal disease

- The patient received more than one biologic and/or more than one hormonal therapy,
administered either concomitantly with platinum-based therapy or separately

- The patient has a history of treatment with other agents targeting PDGF or PDGFR

- The patient has an increased level of CA-125 in the absence of concomitant clinical
or radiographic progression

- The patient has received radiotherapy, chemotherapy, or biologic therapy directed at
the malignant tumor within 3 weeks prior to randomization, or hormonal therapy
directed at the malignant tumor within 1 week prior to randomization. Continuation of
hormone replacement therapy is permitted

- The patient has a suspected impending bowel obstruction (including partial
obstruction), based on clinical or radiographic data

- The patient has a history of allergic reactions attributed to compounds of chemical
or biologic composition similar to that of IMC-3G3

- The patient has an uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection requiring parenteral antibiotics, symptomatic congestive
heart failure,uncontrolled hypertension, clinically significant cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study
requirements

- The patient has a history of another primary cancer, with the exception of: a)
curatively resected nonmelanomatous skin cancer; b) curatively treated cervical
carcinoma in-situ; or c) other primary solid tumor treated with curative intent and
no known active disease present and no treatment administered during the last 3 years
prior to randomization

- The patient is pregnant or lactating

- The patient has ongoing side effects ≥ Grade 2 due to agents administered more than
28 days prior to randomization. The exceptions for such effects are allowed lab
values and toxicities of ≤ Grade 2, specified in the inclusion criteria

- The patient has unstable angina pectoris, angioplasty, cardiac stenting, or
myocardial infarction 6 months prior to randomization

- The patient has participated in clinical trials of experimental agents within 28 days
prior to randomization

- The patient has a history of uncontrolled hereditary or acquired bleeding or
thrombotic disorders

- The patient has a serious or nonhealing active wound, ulcer, or bone fracture

- The patient has known human immunodeficiency virus positivity

- The patient had a major surgical procedure, an open biopsy, or significant traumatic
injury within 28 days prior to randomization

- The patient has received an anthracycline for any indication in the past