Ovarian Cancer Clinical Trials

• Patients with recurrent ovarian/fallopian tube/primary peritoneal cancer for whom liposomal Doxorubicin would be an acceptable therapeutic option will be recruited. Patients are eligible if they have received first line chemotherapy containing platinum and have become platinum resistance or have refractory disease. The patient must also meet all the following criteria:

• Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study

• Female patients, age ≥ 18 years

• Pathological confirmed ovarian, fallopian tube, or primary peritoneal carcinoma with the one of the following histologic types: high grade papillary serous carcinoma, low grade papillary serous carcinoma, high grade mucinous carcinoma, low grade mucinous carcinoma, clear cell carcinoma, high grade endometrioid carcinoma.

• Received at least one line chemotherapy, which must be a platinum containing regimen and develop platinum resistance. Patients may have not received previous liposomal doxorubicin therapy, and must be considered to be eligible for single agent liposomal doxorubicin treatment.

• Patients may have undergone surgical cytoreduction at the time of primary diagnosis or following neoadjuvant chemotherapy. Patients who had optimal (\<1 cm residual disease) or suboptimal (\>1 cm residual disease) following surgical cytoreduction will be included.

• Patients who did not undergo surgical cytoreduction will also be included.

• Recurrent disease confirmed by biopsy, radiologic imaging, and/or elevated CA 125

• Patients may have received radiation therapy

• Life expectancy \> 6 months

• Part 1: Have evaluable disease by radiologic measurements (See 11) or CA 125

⁃ Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as \> 1 cm on cross-sectional imaging (where the CT slice thickness is no greater than 5 mm) or at least 2 cm by standard techniques; positron emissions tomography (PET\] and ultrasound are not permitted methods for tumor measurements under this protocol. Consult RECIST 1.1 guidance for additional information (Appendix C and Eisenhauer et al., 2009; Ref 61).

⁃ Adequate organ function within 14 days prior to first WFA/ASWD dose or liposomal doxorubicin whichever occurs first, including the following: absolute neutrophil count (ANC) ≥ 1.5 x 103/L, platelet count ≥ 100 x 103/L, hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L), patients may receive packed RBC transfusion to achieve this level at the discretion of the investigator, total bilirubin \< 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease, aspartate aminotransferase (AST) \< 3 x ULN (\< 5 x ULN in the presence of hepatic metastases), alanine aminotransferase (ALT) \< 3 x ULN (\< 5 x ULN in the presence of hepatic metastases), alkaline phosphatase \< 3.0 x ULN, calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula

⁃ Satisfy one of the following:

∙ Females: non-pregnant and non-lactating; surgically sterile, post- menopausal, or patient/partner compliant with a reliable contraceptive regimen, as determined by the investigator, for 4 weeks prior to screening.

‣ Patients of reproductive potential must test negative for pregnancy at screening, prior to each cycle, and must agree to use a reliable method of birth control during the study period and 6 months following completion of treatment.

⁃ The patient is willing and able to comply with the study visit schedule and procedures and has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol

⁃ For Part 1: Patients have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks prior to study treatment and have recovered from the acute effects of therapy

⁃ ECOG performance status of 0, 1, or 2

⁃ Adequate ejection fraction determined by transthoracic echo or MUGA of at least 55%

⁃ Patients may have received prior anthracycline or anthracenedione therapy. In this scenario, the use of prior treatments will be incorporated into the cumulative dose calculations when applicable, given a known increased risk of cardiomyopathy to 11% when the cumulative dose of liposomal doxorubicin was between 450 mg/m2 to 550 mg/m2.

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