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Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03562533
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Seoul National University Hospital
National Cancer Center, Korea
Asan Medical Center
The Catholic University of Korea
Samsung Medical Center
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Ajou University
Severance Hospital
Information provided by (Responsible Party):
Konkuk University Medical Center

Brief Summary:
This retrospective multicenter study aimed to evaluate the effectiveness of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with carboplatin and paclitaxel (CP) in patients who had disease progression longer than 6 months after first-line platinum+taxane chemotherapy for ovarian cancer in real world clinical practice.

Condition or disease Intervention/treatment
Ovarian Carcinoma Drug: pegylated liposomal doxorubicin (PLD) + carboplatin (CD) Drug: carboplatin + paclitaxel (CP)

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 432 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparison of Real-World Effectiveness of Pegylated Liposomal Doxorubicin Versus Paclitaxel in Platinum- Sensitive Recurrent Ovarian Cancer
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018


Group/Cohort Intervention/treatment
pegylated liposomal doxorubicin + carboplatin
carboplatin area under the curve [AUC] 5 plus pegylated liposomal doxorubicin (PLD) 30 mg/m2 every 4 weeks
Drug: pegylated liposomal doxorubicin (PLD) + carboplatin (CD)
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles

paclitaxel + carboplatin
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks
Drug: carboplatin + paclitaxel (CP)
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 36 months ]
    OS was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 3years ]
    PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria.

  2. Incidence of Treatment-Related Adverse Events [ Time Frame: 36 months ]
    Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.

  3. Response rate [ Time Frame: 36 months ]
    Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
A histologically confirmed diagnosis of epithelial ovarian, tubal, and primary peritoneal cancer, and recurred >6 months after first-line platinum-based chemotherapy regimen
Criteria

Inclusion Criteria:

  • Previous taxane therapy was required.
  • Recurred >6 months after surgery and first-line platinum-based chemotherapy regimen
  • Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or CA-125 assessable disease according to Gynecologic Cancer InterGroup (GCIG) criteria or histologic proven diagnosis
  • Eastern Cooperative Oncology Group performance status of ≤ 2

Exclusion Criteria:

  • Had ovarian tumors of low malignant potential (borderline tumors); nonepithelial or mixed epithelial/nonepithelial tumors (eg, mixed Mullerian tumors)
  • Had received prior radiotherapy; or, had a previous diagnosis of malignancy within the past 5 years.
  • Had bowel obstruction or presence of symptomatic brain metastases
  • Patients with severe active infection
  • Had history of severe hypersensitivity reactions to compounds chemically related to study products.

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): NCT03562533


Locations
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Korea, Republic of
Konkuk University School of Medicine
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Konkuk University Medical Center
Seoul National University Hospital
National Cancer Center, Korea
Asan Medical Center
The Catholic University of Korea
Samsung Medical Center
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Ajou University
Severance Hospital
Investigators
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Principal Investigator: Seung Hyuk Shim, MD Konkuk University Hospital

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Responsible Party: Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT03562533     History of Changes
Other Study ID Numbers: KUH1040075
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors