Status:
UNKNOWN
Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant o...
Detailed Description
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. Approximately 75% of patients are diagnosed at an advanced stage will eventually experience disease recurrence....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
- Platinum resistant or refractory ovarian cancer
- At least treated with one line of platinum-based chemotherapy
- Female, age ≥18 years and ≤70 years, signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
- Patients must have a life expectancy of at least 3 months.
- Patients must have adequate organ function as defined by the following criteria:
- White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.0 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 80 x 10\^9/L
- Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN
- Serum creatinine ≤ 1 x ULN
- Symptomatic central nervous system (CNS) metastasis
- Exclusion Critera:
- Has known allergies to any of the excipients.
- Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin
- LVEF (left ventricular ejection fraction) \<50%
- Had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy
- History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
- Known significant chronic liver disease, such as cirrhosis or active hepatitis
- Uncontrollable active infection
Exclusion
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03335241
Start Date
March 1 2017
End Date
December 1 2022
Last Update
November 13 2017
Active Locations (1)
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1
Sun Yat-sen University Cancer
Guangzhou, Guangdong, China, 510060