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Trial record 52 of 2158 for:    doxorubicin

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

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ClinicalTrials.gov Identifier: NCT03335241
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jundong Li, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Fludarabine and Pegylated liposomal doxorubicin Drug: Pegylated liposomal doxorubicin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Arm 1: Fludarabine and Pegylated liposomal doxorubicin 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


Active Comparator: Arm 2: Pegylated liposomal doxorubicin Drug: Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to four years ]
    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 :
  1. Objective response rate [ Time Frame: Up to four years ]
    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.


Other Outcome Measures:
  1. Frequency and severity of adverse effects as defined by CTCAE version 4.0 [ Time Frame: 30 days after last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335241


Contacts
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Contact: Jundong Li +86-20-87343104 lijd@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jundong Li    +86-20-87343104    lijd@sysucc.org.cn   
Contact: Yin Wang    +86-20-87343104    wangyin@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Jundong Li, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03335241     History of Changes
Other Study ID Numbers: 308-2016-03-01
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jundong Li, Sun Yat-sen University:
Ovarian Cancer
Fludarabine
Pegylated Liposomal Doxorubicin
Chemotherapy
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vidarabine
Fludarabine
Fludarabine phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors