Phase
Condition
Fallopian Tube Cancer
Ovarian Cysts
Pelvic Cancer
Treatment
Pegylated liposomal doxorubicin
Bevacizumab
Carboplatin
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed high-grade serous epithelial ovariancarcinoma, fallopian tube, or peritoneal carcinoma.
Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy inthe advanced or metastatic setting.
Measurable disease per RECIST version 1.1.
Adequate hematologic and organ function as defined by the following criteria:
ANC ≥ 1.5 × 10^9/L; excluding measurements obtained within 7 days after dailyadministration of filgrastim/sargramostim or within 3 weeks afteradministration of pegfilgrastim.
Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 daysafter transfusion of platelets or within 3 weeks after administration ofplatelet growth factors.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upperlimit of normal (ULN). If liver function abnormalities are due to underlyingliver metastases, AST and ALT ≤ 5 x ULN.
Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert'sdisease.
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
Exclusion
Exclusion Criteria:
Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderlineovarian tumor.
Any of the following treatment interventions within the specified time frame priorto Cycle 1 Day 1:
Major surgery within 28 days.
Radiation therapy within 21 days.
Autologous or allogeneic stem cell transplant within 3 months.
A serious illness or medical condition(s) including, but not limited to, the following:
Brain metastases that require immediate treatment or are clinically orradiographically unstable.
Myocardial impairment of any cause.
Significant gastrointestinal abnormalities.
Active or uncontrolled infection.
Any evidence of small bowel obstruction as determined by air/fluid levels oncomputed tomography (CT) scan, recent hospitalization for small bowel obstructionwithin 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesiswithin 6 weeks prior to Cycle 1 Day 1.
- Subjects with active (uncontrolled, metastatic) second malignancies orrequiring therapy.
Study Design
Connect with a study center
Clinical Site 10
Brisbane, Queensland 4102
AustraliaSite Not Available
Site 2707
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Site 2708
Sunshine Coast, Queensland 4556
AustraliaActive - Recruiting
Site 2709
Adelaide, South Australia 5000
AustraliaSite Not Available
Site 2706
Melbourne, Victoria 3144
AustraliaActive - Recruiting
Site 2716
Melbourne, Victoria 3121
AustraliaActive - Recruiting
Site 2705
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Site 1001
Banja Luka, 78000
Bosnia and HerzegovinaCompleted
Site 1002
Sarajevo, 71000
Bosnia and HerzegovinaCompleted
Site 1003
Tuzla, 75000
Bosnia and HerzegovinaCompleted
Site 1202
Panagyurishte, 4500
BulgariaCompleted
Site 1201
Sofia, 1632
BulgariaCompleted
Site 1401
Tbilisi, 0112
GeorgiaSite Not Available
Site 2901
Busan,
Korea, Republic ofCompleted
Site 2903
Seoul, 03080
Korea, Republic ofCompleted
Site 2904
Seoul, 05505
Korea, Republic ofCompleted
Site 1902
Belgrade, 11080
SerbiaCompleted
Site 0264
Aurora, Colorado 80045
United StatesActive - Recruiting
Site 0104
Boston, Massachusetts 02215
United StatesActive - Recruiting
Site 0111
Saint Louis, Missouri 53110
United StatesActive - Recruiting
Site 0173
New York, New York 10029
United StatesActive - Recruiting
Site 0259
Durham, North Carolina 27710
United StatesActive - Recruiting
Site 0191
Providence, Rhode Island 02905
United StatesActive - Recruiting
Site 0196
Nashville, Tennessee 37203
United StatesCompleted
Site 0103
Houston, Texas 77030
United StatesActive - Recruiting
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