Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer

  • STATUS
    Recruiting
  • End date
    Dec 21, 2022
  • participants needed
    140
  • sponsor
    Sun Yat-sen University
Updated on 21 January 2021
measurable disease
carcinoma
doxorubicin
metastasis
neutrophil count
cancer chemotherapy
solid tumour
platinum-based chemotherapy
ovarian epithelial carcinoma
cancer of the ovary

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 or refractory ovarian cancer.

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. The overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. The 5-year overall survival rates are less than 20%. Therefore, it is important to seek alternative agent that can improve the outcome. Fludarabine is a purine nucleoside analog prodrug that upon phosphorylation is toxic to dividing and quiescent lymphocytes and monocytes, exerting its effects through DNA synthesis interference and apoptosis. The preclinical studies suggest fludarabine may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug fludarabine combined with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.

Details
Condition Ovarian disorder, Ovarian Cancer, Ovarian Function, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment Pegylated Liposomal Doxorubicin, Fludarabine and Pegylated liposomal doxorubicin
Clinical Study IdentifierNCT03335241
SponsorSun Yat-sen University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have Ovarian Cancer?
Do you have any of these conditions: Ovarian Function or ovarian tumors or cancer of the ovary or ovarian carcinomas or cancer ovarian or Recurrent Ovarian Cancer or Ovarian disorder or c...?
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
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