Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
Primary Peritoneal Cancer
Brief summary
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Interventions
DRUGAMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
DRUGPaclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
DRUGAMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
DRUGCarboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded * Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization * Subjects with FIGO Stage IIIC or IV disease must either: * Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or * Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer * ECOG performance status of 0 or 1 * Adequate bone marrow, renal and hepatic function
Exclusion criteria
* Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer * Previous abdominal and/or pelvic external beam radiotherapy * History of central nervous metastasis * History of arterial or venous thromboembolism within 12 months prior to randomization * Clinically significant cardiovascular disease within 12 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events and significant laboratory abnormalities | 4 years | — |
| Pharmacokinetics of AMG 386 (Cmax and Cmin) | 1 year | pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7 |
| Incidence of anti-AMG 386 antibody formation | 4 years | pre-dose weeks 1, 10, 19 |
| Overall survival (OS) | 5 years | — |
| Patient reported status as measured by the EuroQOL (EQ-5D) | 4 years | — |
| AMG 386 exposure-response relationships for PFS and OS | 4 years | — |
| Correlation of serum biomarkers with measures of response | 4 years | — |
| Patient reported ovarian cancer-specific symptoms and health related quality of life | 4 years | — |
Countries
Austria, Belgium, Canada, Denmark, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Russia, South Korea, Spain, United States
Outcome results
None listed