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

NCT ID: NCT03335241

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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Ovarian Cancer Fludarabine Pegylated Liposomal Doxorubicin Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Fludarabine and Pegylated liposomal doxorubicin

Group Type EXPERIMENTAL

Fludarabine and Pegylated liposomal doxorubicin

Intervention Type DRUG

Fludarabine 25mg/m2 iv on days d1-d3 of each 4-week cycle

Pegylated liposomal doxorubicin 30mg/m2 iv every 4 weeks

Arm 2: Pegylated liposomal doxorubicin

Group Type ACTIVE_COMPARATOR

Pegylated liposomal doxorubicin

Intervention Type DRUG

Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks

Interventions

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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

Intervention Type DRUG

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Jundong Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jundong Li

Role: CONTACT

Phone: +86-20-87343104

Email: [email protected]

Facility Contacts

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Jundong Li

Role: primary

Yin Wang

Role: backup

Other Identifiers

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308-2016-03-01

Identifier Type: -

Identifier Source: org_study_id