Clinical trial NCT01253681 (phase 1, status: completed)
Conditions: carcinoma, fallopian tube cancer, ovarian cancer, primary peritoneal cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: amg 386, paclitaxel and carboplatin
SMILES: [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects more than 18 years of age with newly diagnosed high-risk FIGO Stage I
             (grade 3, or aneuploid grade 1 or 2) or Stages II-IV epithelial ovarian, primary
             peritoneal and fallopian tube cancer with an indication for first-line treatment with
             paclitaxel and carboplatin x 6 cycles. Subjects with pseudomyxoma, mesothelioma,
             adenocarcinoma of unknown primary tumor, sarcoma, or neuroendocrine histology are
             excluded.

          -  Subjects with high-risk stage I, stage II, or stage IIIA-B must have had prior primary
             debulking surgery that occurred no less than 4 weeks, and no more than 12 weeks, prior
             to enrollment. Subjects must have recovered fully from surgery in the opinion of the
             investigator

          -  Subjects with Stage IIIC or IV disease who have not had primary debulking surgery must
             have planned interval debulking surgery following 3 cycles of AMG 386, paclitaxel and
             carboplatin

          -  Female 18 years of age or older at the time the written informed consent is obtained

          -  Subjects of child-bearing potential who have not undergone a bilateral
             salpingo-oophorectomy and are sexually active must consent to use an accepted and
             effective non-hormonal method of contraception (i.e, double barrier method (eg, condom
             plus diaphragm) from signing the informed consent through 6 months after last dose of
             study drug

          -  GOG Performance Status of 0 or 1

          -  Life expectancy ≥ 3 months (per investigator opinion)

          -  Subject plans to begin protocol-directed therapy within 7 days from enrollment

          -  Adequate organ and hematological function as evidenced by the following laboratory
             studies prior to enrollment:

        Hematological function, as follows:

          -  Hemoglobin ≥ 9 g/dL

          -  Absolute neutrophil count (ANC) ≥ 1.5 x 10x9/L

          -  Platelet count ≥ 100 x 10x9/L and ≤ 850 x 10x9/L

          -  PTT or aPTT ≤ 1.5 x ULN per institutional laboratory range and INR ≤ 1.5

        Renal function, as follows:

          -  Urinary protein quantitative value of ≤ 30 mg/dL in urinalysis or ≤ 1+ on dipstick,
             unless quantitative protein is < 1000 mg in a 24 hour urine sample

          -  Creatinine clearance > 40 mL/min per 24-hr urine collection or calculated according to
             the Cockcroft-Gault formula

        Hepatic function, as follows:

          -  AST and ALT ≤ 2.5 x ULN per institutional laboratory range (or ≤ 5 x ULN if liver
             metastases are present)

          -  Total bilirubin ≤ 1.5x institutions' ULN Nutritional

          -  Albumin ≥ 2.8 g/dL

        Exclusion Criteria:

          -  Prior use of anticancer therapy or experimental therapy for epithelial ovarian,
             primary peritoneal or fallopian tube cancers

          -  Previous abdominal and/or pelvic external beam radiotherapy

          -  Subjects believed to be a higher than average risk of bowel perforation. This includes
             current symptoms of partial or complete bowel obstruction, recent (within 6 months)
             history of fistula or bowel perforation, subjects requiring total parenteral nutrition
             and continuous hydration

          -  History of arterial or venous thromboembolism within 12 months prior to enrollment

          -  History of clinically significant bleeding within 6 months prior to enrollment

          -  History of central nervous system metastasis

          -  Known active or ongoing infection (except uncomplicated urinary tract infection)
             within 14 days prior to enrollment

          -  Currently or previously treated with AMG 386, or other molecules that inhibit the
             angiopoietins or Tie2 receptor

          -  Current or within 30 days prior to enrollment treatment with immune modulators such as
             systemic cyclosporine or tacrolimus

          -  Prior myeloablative high-dose chemotherapy with allogeneic or autologous stem cell (or
             bone marrow) transplant

          -  Clinically significant cardiac disease within 12 months prior to enrollment, including
             myocardial infarction, unstable angina, grade 2 or greater peripheral vascular
             disease, cerebrovascular accident, transient ischemic attack, congestive heart
             failure, or arrhythmias not controlled by outpatient medication or placement of
             percutaneous transluminal coronary angioplasty/stent

          -  Uncontrolled hypertension as defined as diastolic blood pressure > 90 mmHg OR systolic
             blood pressure > 140 mmHg. The use of anti-hypertensive medications to control
             hypertension is permitted

          -  Subjects with a history of prior malignancy, except:

        Malignancy treated with curative intent and with no known active disease present for ≥ 3
        years prior to enrollment and felt to be at low risk for recurrence by treating physician,
        Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of
        disease Adequately treated cervical carcinoma in situ without evidence of disease

          -  Major surgery within 28 days prior to enrollment or still recovering from prior
             surgery

          -  Minor surgical procedures, including placement of tunneled central venous access
             device, within 3 days prior to enrollment

          -  History of allergic reactions to bacterially-produced proteins

          -  Hypersensitivity to paclitaxel or drugs using the vehicle cremophor

          -  Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding or
             planning to become pregnant within 6 months after the end of treatment

          -  Subject has known positive test(s) for human immunodeficiency virus (HIV) infection,
             hepatitis C virus, acute or chronic active hepatitis B infection

          -  Any condition which in the investigator's opinion makes the subject unsuitable for
             study participation

          -  Any uncontrolled concurrent illness or history of any medical condition that may
             interfere with the interpretation of the study results

          -  Non-healing wound, ulcer (including gastrointestinal) or fracture

          -  Subject has previously been enrolled onto this study

          -  Subject will not be available for follow-up assessment

          -  Subject has known sensitivity to any of the products to be administered during dosing

          -  Subject has any kind of disorder that compromises the ability of the subject to give
             written informed consent and/or to comply with study procedures