Clinical trial NCT00407563 (phase 2, status: completed)
Conditions: epithelial ovarian cancer, primary peritoneal carcinoma
ICD codes: H18.523, H18.521, H18.522, H18.529, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: bevacizumab, abraxane
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Measurable disease by CT or MRI.

          -  At least 1 "target lesion" to be used to assess response as defined by GOG RECIST
             criteria.

          -  ECOG performance status of 0 or 1.

          -  Patient provides voluntary written informed consent.

          -  At least 18 years of age.

          -  Negative serum pregnancy test.

          -  Recovered from any recent surgery for at least 30 days and is free of active
             infection.

          -  Received the following prior therapy at time of enrollment:

          -  Must have had 1 prior platinum-based chemotherapeutic regimen containing carboplatin,
             cisplatin or organoplatinum. Initial therapy may have included high-dose therapy,
             consolidation, or extended therapy. Patient should be defined as recurrent or
             progression of disease within 6 months of last platinum chemotherapy.

          -  May have had 1 additional cytotoxic or non-cytotoxic chemotherapy regimen.

          -  Must have adequate hematologic and hepatic function.

        Exclusion Criteria:

          -  Previously received bevacizumab.

          -  History of other invasive malignancy with the exception of nonmelanoma skin cancer.

          -  ECOG performance status of 2, 3, or 4.

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored
             bevacizumab cancer study. Patient must be bevacizumab naïve.

          -  Blood pressure of >150/100 mm Hg on antihypertensive medications.

          -  Prior history of hypertensive crisis or hypertensive encephalopathy.

          -  Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart
             failure.

          -  History of myocardial infarction within 6 months of enrollment.

          -  History of stroke or transient ischemic attack within 6 months prior to study
             enrollment.

          -  Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection)or
             symptomatic peripheral vascular disease.

          -  Bleeding diathesis or coagulopathy.

          -  Presence of CNS or brain metastases.

          -  Pre-existing peripheral neuropathy of Grade ≥ 2.

          -  A major surgical procedure, open biopsy, or significant traumatic injury within 28
             days prior to study enrollment or anticipation of need for major surgical procedure
             during the course of the study.

          -  A partial or complete small or large bowel obstruction demonstrated radiologically
             within 3 months prior to study enrollment.

          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular
             access device, within 7 days prior to study enrollment.

          -  Positive pregnancy test or is lactating.

          -  History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6
             months prior to study enrollment.

          -  Serious, non-healing wound, ulcer, or bone fracture.

          -  Serious intercurrent medical or psychiatric illness, including serious active
             infection.

          -  Inability to comply with study and/or follow-up procedures.

          -  Life expectancy of less than 12 weeks.

          -  Proteinuria at screening as demonstrated by either:

          -  Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR

          -  Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on
             dipstick urinalysis at baseline should undergo a 24 hour urine collection and must
             demonstrate ≤ 1g of protein in 24 hours to be eligible).

          -  Known hypersensitivity to any component of bevacizumab.