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Health Condition(s) or Problem
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Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer
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Lay Summary
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The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is
superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or
resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
AMG 386 is a man-made medication that is designed to stop the development of blood vessels
in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process
called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Female 18 years of age or older at the time the written informed consent is obtained
- Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
- Life expectancy >= 3 months (per investigator opinion)
- Histologically or cytologically documented invasive epithelial ovarian cancer,
primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma ,
mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with
borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with
clear cell or mucinous histology are excluded)
- Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer,
or fallopian tube cancer including at least a unilateral oophorectomy
- Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 with modifications
- Subjects must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound. This initial treatment may have included intraperitoneal
therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy
administered after surgical or non-surgical assessment.
- Adequate organ and hematological function
- Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and
diastolic blood pressure <= 90 mmHg prior to randomization. The use of
anti-hypertensive medications to control hypertension is permitted
- Radiographically documented disease progression either on or following the last dose
of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal
cancer, or fallopian tube cancer
Exclusion Criteria:
- Subjects who have received more than 3 previous regimens of anti-cancer therapy for
epithelial ovarian, primary peritoneal or fallopian tube cancers
- Subjects who have received paclitaxel as consolidation therapy, maintenance, or
monotherapy are excluded
- Subjects with primary platinum-refractory disease
- Subjects with platinum-free interval (PFI) > 12 months from their last platinum based
therapy
- Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from
all radiotherapy-related toxicities
- Previous abdominal or pelvic radiotherapy
- History of arterial or venous thromboembolism within 12 months prior to randomization
- History of clinically significant bleeding within 6 months prior to randomization
- History of central nervous system metastasis
- Has not yet completed a 21 day washout period prior to randomization for any previous
anti cancer systemic therapies (30 days for prior bevacizumab)
- Enrolled in or has not yet completed at least 30 days (prior to randomization) since
ending other investigational device or drug, or currently receiving other
investigational treatments
- Unresolved toxicities from prior systemic therapy that are Common Terminology
Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except
alopecia
- Known active or ongoing infection (except uncomplicated urinary tract infection
[UTI]) within 14 days prior to randomization
- Currently or previously treated with AMG 386, or other molecules that inhibit the
angiopoietins or Tie2 receptor
- Treatment within 30 days prior to randomization with strong immune modul
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Who cannot enter the trial
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Inclusion Criteria:
- Female 18 years of age or older at the time the written informed consent is obtained
- Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
- Life expectancy >= 3 months (per investigator opinion)
- Histologically or cytologically documented invasive epithelial ovarian cancer,
primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma ,
mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with
borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with
clear cell or mucinous histology are excluded)
- Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer,
or fallopian tube cancer including at least a unilateral oophorectomy
- Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 with modifications
- Subjects must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound. This initial treatment may have included intraperitoneal
therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy
administered after surgical or non-surgical assessment.
- Adequate organ and hematological function
- Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and
diastolic blood pressure <= 90 mmHg prior to randomization. The use of
anti-hypertensive medications to control hypertension is permitted
- Radiographically documented disease progression either on or following the last dose
of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal
cancer, or fallopian tube cancer
Exclusion Criteria:
- Subjects who have received more than 3 previous regimens of anti-cancer therapy for
epithelial ovarian, primary peritoneal or fallopian tube cancers
- Subjects who have received paclitaxel as consolidation therapy, maintenance, or
monotherapy are excluded
- Subjects with primary platinum-refractory disease
- Subjects with platinum-free interval (PFI) > 12 months from their last platinum based
therapy
- Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from
all radiotherapy-related toxicities
- Previous abdominal or pelvic radiotherapy
- History of arterial or venous thromboembolism within 12 months prior to randomization
- History of clinically significant bleeding within 6 months prior to randomization
- History of central nervous system metastasis
- Has not yet completed a 21 day washout period prior to randomization for any previous
anti cancer systemic therapies (30 days for prior bevacizumab)
- Enrolled in or has not yet completed at least 30 days (prior to randomization) since
ending other investigational device or drug, or currently receiving other
investigational treatments
- Unresolved toxicities from prior systemic therapy that are Common Terminology
Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except
alopecia
- Known active or ongoing infection (except uncomplicated urinary tract infection
[UTI]) within 14 days prior to randomization
- Currently or previously treated with AMG 386, or other molecules that inhibit the
angiopoietins or Tie2 receptor
- Treatment within 30 days prior to randomization with strong immune modul
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What will happen
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Drug; AMG 386; Weekly Intravenous (IV) AMG 386 15 mg/kg plus IV paclitaxel 80 mg/m2 weekly (3 on / 1 off); AMG 386; Drug; AMG 386 Placebo; Weekly Intravenous (IV) placebo plus IV paclitaxel 80 mg/m2 weekly (3 on / 1 off); AMG 386 Placebo
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Primary aim
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Progression-Free Survival
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Secondary Aim
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Overall survival; 20 months on average; No; Objective Response Rate; From Baseline (if subject has Measurable Disease) until objective response (radiologic); No; Duration of response; From Baseline until progression; No; CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125; From Baseline until CA-125 response; No; Incidence of adverse events and significant laboratory abnormalities; 8 Months on average; Yes; Pharmacokinetics of AMG 386 (Cmax and Cmin); Week 1 until week 9 of treatment; No; Incidence of the occurrence of anti-AMG 386 antibody formation; Week 1 until maximum of 1-year following last dose of study drug; Yes; Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O); From week 1 until 30-days following last study drug administration; No; Overall health status using EuroQOL(EQ-5D); From week 1 until 30-days following last study drug administration; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.amgentrials.com
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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London, Manchester, Northwood, Nottingham, Poole, Sutton
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