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

Ovarian Cancer Clinical Trial

Official title:

An Open-label, Randomised Phase II Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03335241
• Other study ID #: 308-2016-03-01
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 2017
• Last updated: November 8, 2017
• Start date: March 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: November 2017
• Source: Sun Yat-sen University
• Contact: Jundong Li
• Phone: +86-20-87343104
• Email: lijd[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Fludarabine and Pegylated liposomal doxorubicin
Fludarabine 25mg/m2 iv on days d1-d3 of each 4-week cycle Pegylated liposomal doxorubicin 30mg/m2 iv every 4 weeks
• Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency and severity of adverse effects as defined by CTCAE version 4.0		30 days after last dose
Primary	Progression-free survival (PFS)	Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD	Up to four years
Secondary	Objective response rate	Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.	Up to four years