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A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer

Inclusion Criteria

Inclusion Criteria -Subjects must have histologically or cytologically documented
epithelial ovarian (FIGO Stage II-IV), fallopian tube or primary peritoneal cancer.

(Subjects with pseudomyxoma or mesothelioma are excluded)

- Radiographically documented progression per RECIST criteria with modifications or
progression of CA-125 as defined by the Rustin during or subsequent to the last
chemotherapy regimen.

- May include measurable or non-measurable disease

- All scans and x-rays used to document measurable or non-measurable disease must be
done within 3 weeks (21 days) of enrollment.

- No more than 3 previous regimens of anti-cancer therapy. Subjects must have received
at least one platinum containing regimen

- 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 use an accepted and effective
non-hormonal method of contraception (ie, double barrier method (eg, condom plus
diaphragm)) from signing the informed consent through 6 months after last dose of
study drug.


- Adequate organ and hematological function as evidenced by the following laboratory
studies within 2 weeks (14 days) of randomization:

- Hematological function, as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L and ≤ 850 x
109/L Hemoglobin ≥ 9 g/dL PTT or aPTT≤ 1.5 x ULN per institutional laboratory rand and INR
≤ 1.5 x 109/L per instiutiona laboratory range

Renal function, as follows:

Creatinine ≤ 2.0 mg/dL Calculated creatinine clearance > 40 cc/min according to the
Cockcroft-Gault formula

-Hepatic function, as follows: Total bilirubin ≤ 2.0 x ULN SGOT (AST) and SGPT (ALT) ≤ 2.5
x ULN (≤ 5 x ULN if liver metastases are present) Nutritional

- Albumin ≥ 2.8 mg/dL General

- GOG Performance Status of 0 or 1

- Subject plans to begin protocol directed therapy within 7 days of randomization

Exclusion Criteria

- Subjects believed to be a higher than average risk for bowel perforation. This
includes 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

- Known ongoing small bowel dysfunction (ie, persistent nausea, vomiting)

- Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all
radiotherapy-related toxicities

- If all sites of disease have been irradiated, documented progression must have
occurred in at least one site of disease subsequent to the radiation therapy.

- Previous abdominal radiotherapy

- Has not yet completed a 21 day washout period for any previous anti-cancer systemic
therapies (60 days for bevacizumab or any molecule of long half-life).

- Enrolled in or has not yet completed at least 30 days since ending other
investigational device or drug study(s), or is receiving other investigational

- Current or prior history of central nervous system metastasis

- Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 peripheral
neuropathy ≥grade 2

- History of arterial or venous thrombosis within 12 months prior to randomization

- Concurrent or prior (within 1 week before study day 1) anticoagulation therapy,
excluding aspirin and anti platelet agents. The concurrent use of low molecular
weight heparin or low dose warfarin (ie, ≤ 1 mg daily) for prophylaxis against
thrombosis is acceptable while on study

- History of bleeding diathesis or clinically significant bleeding within 14 days of

- Major surgical procedure within 4 weeks (28 days) prior to Study Day 1

- Minor surgical procedure, or placement of central venous access device, within 7 days
of Study Day 1

- Paracentesis and/or thoracentesis are permitted prior to and while on study at the
discretion of the investigator as clinically indicated. Investigators should
document the frequency of paracenteses and/or thoracentesis that occurred prior to
the enrollment of the subject in this study on the appropriate eCRFs. Investigators
should also document each paracentesis and/or thoracentesis that occurs while a
subject is on study on the appropriate eCRFs.

- Subjects with a history of prior malignancy, except:

- Malignancy treated with curative intent and with no known active disease present for
≥ 3 years before enrollment and felt to be at low risk for recurrence by treating

- Adequately treated non melanomatous skin cancer or lentigo maligna without evidence
of disease

- Adequately treated cervical carcinoma in situ without evidence of disease

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

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

- Non-healing wound, ulcer or fracture

- Ongoing or active infection

- Unacceptable hypersensitivity to paclitaxel or drugs containing cremophor

- Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis
B surface antigen

- Currently or previously treated with angiopoietin inhibitors, or inhibitors of TIE-1
or TIE-2 including, but not limited to, AMG 386, XL880, XL820

- Prior therapy against vascular endothelial growth factor or the vascular endothelial
growth factor receptors including, but not limited to, bevacizumab, sunitinib,
sorafenib, motesanib (AMG 706) or cediranib (AZD-2171), is permitted so long as the
agent does not have any known activity against angiopoietin 1 or 2, or the receptors
TIE-1 or TIE-2

- Current or within 30 days of randomization treatment with immune modulators such as
cyclosporine and tacrolimus

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Therapeutic Goods Administration

Study ID:




Start Date:

July 2007

Completion Date:

April 2013

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Advanced Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms