A Phase II Study of Atrasentan (ABT-627) Plus DOXIL in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma arising from the ovary,
fallopian tubes, or peritoneum (i.e., peritoneal serous papillary adenocarcinoma)

- Received prior treatment with either cisplatin or carboplatin in combination with
paclitaxel or docetaxel as first-line chemotherapy

- Radiographic evidence of progressive disease and/or a doubling of CA-125 levels ≥ 70
IU/mL following first-line chemotherapy

- Measurable disease as defined by RECIST criteria

- No CNS metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/μL

- Hemoglobin ≥ 9.5 g/dL

- Platelets > 100,000/μL

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if liver metastases are present)

- LVEF ≥ 50% by MUGA

- Not pregnant or nursing

- Negative pregnancy test

- Surgically sterile or must use effective contraception

- No known HIV positivity or AIDS

- No uncontrolled heart disease, diabetes, or other medical condition that would place
the patient at unacceptably high risk for toxicity

- No New York Heart Association class I-IV heart failure

Exclusion Criteria:

Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from all prior toxicities to ≤ grade 1 by NCI-CTC Version 2 criteria

- No other prior systemic therapies for this cancer except cisplatin or carboplatin in
combination with paclitaxel or docetaxel as first-line chemotherapy

- More than 4 weeks since prior chemotherapy

- No concurrent anticancer therapy