search
Back to results

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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fludarabine and Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Fludarabine, Pegylated Liposomal Doxorubicin, Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University CancerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Fludarabine and Pegylated liposomal doxorubicin

Arm 2: Pegylated liposomal doxorubicin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 1, 2017
Last Updated
November 8, 2017
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT03335241
Brief Title
Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 or refractory ovarian cancer.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, Fludarabine, Pegylated Liposomal Doxorubicin, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Fludarabine and Pegylated liposomal doxorubicin
Arm Type
Experimental
Arm Title
Arm 2: Pegylated liposomal doxorubicin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fludarabine and Pegylated liposomal doxorubicin
Intervention Description
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
Intervention Name(s)
Pegylated liposomal doxorubicin
Intervention Description
Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Time Frame
Up to four years
Secondary Outcome Measure Information:
Title
Objective response rate
Description
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.
Time Frame
Up to four years
Other Pre-specified Outcome Measures:
Title
Frequency and severity of adverse effects as defined by CTCAE version 4.0
Time Frame
30 days after last dose

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jundong Li
Phone
+86-20-87343104
Email
lijd@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jundong Li
Phone
+86-20-87343104
Email
lijd@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yin Wang
Phone
+86-20-87343104
Email
wangyin@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs