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Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer

Primary Purpose

Efficacy and Safety

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin
paclitaxel
Carboplatin
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy and Safety focused on measuring PEGylated Doxorubicin Hydrochloride Liposome Injection, Duomeisu, First-line treatment, Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-75years old;
  • Histopathologically or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer;
  • According to the International Federation of Obstetrics and Gynecology (FIGO), the stage is Ic-IV;
  • Imaging assessment is based on the solid tumor efficacy evaluation standard (RECIST) version 1.1, lesions can be measured, or patients' CA125 assessed according to GCIG criteria;
  • Neoadjuvant chemotherapy can be given to patients with excessive tumor volume or a wide range of lesions, who are not expected to achieve ideal cytoreductions before surgery;
  • ECOG score ≤ 2;
  • Expected survival time ≥ 3 months;
  • LVEF ≥ 50%;
  • Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
  • Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or <ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present;
  • The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating;
  • Signed the informed consent.

Exclusion Criteria:

  • Patients with low-grade malignant potential ovarian tumors;
  • Patients who had previously received chemotherapy or pelvic and abdominal radiotherapy;
  • Patients planning to receive abdominal or pelvic chemotherapy;
  • The New York Heart Association (NYHA) graded class II heart disease patients (including grade II) previous or current;
  • Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
  • Uncontrolled systemic infection requiring anti-infective treatment;
  • Allergies to chemotherapeutic drugs or their excipients or intolerant patients;
  • Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
  • Researchers think it is not suitable for enrolling.

Sites / Locations

  • Women's Hospital School Of Medicine Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

chemotherapy

Arm Description

pegylated liposomal doxorubicin 30 mg/m2, i.v.,d1; carboplatin AUC 5,i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.

paclitaxel 175 mg/m2, i.v.,d1; carboplatin AUC 5, i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.

Outcomes

Primary Outcome Measures

PFS
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.

Secondary Outcome Measures

OS
overall survival
ORR
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment.
DCR
DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
the incidence and severity of adverse reactions
Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.
quality of life assessment
according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception.

Full Information

First Posted
December 24, 2018
Last Updated
July 14, 2022
Sponsor
Women's Hospital School Of Medicine Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03794778
Brief Title
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
Official Title
Evaluation of PEGylated Doxorubicin Hydrochloride Liposome Injection(Duomeisu®) Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer: A Randomized, Open, Multicenter Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang 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
This is a randomized, multicenter, open, controlled Post-Marketing Study. 396 patients who were histopathology or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant chemotherapy), residual disease after surgery (>1cm, <1cm, no primary surgery), stage (Ic, II, III or IV), pathological typing, Eastern Cooperative Oncology Group performance status (0 to 1 or 2), BRCA1/2 gene mutation.
Detailed Description
Subjects will receive one of two treatment regimens: Group A: intravenous infusion of liposomal doxorubicin 30 mg/m2, d1; carboplatin AUC 5 (dosed according to the Calvert formula, with creatinine clearance estimated according to the Cockcroftformula), intravenous infusion, d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage. Group B: intravenous infusion of paclitaxel 175 mg/m2, d1; carboplatin AUC 5, intravenous infusion, d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage. Treatment was initially administered for three cycles, and patients with stable or responding disease continued treatment for further a three cycles. The main purpose is to evaluate the efficacy and safety of liposomal doxorubicin plus carboplatin in the first-line treatment of epithelial ovarian cancer. The primary endpoint is progression free survival (PFS), the secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR):CR+PR+SD, the incidence and severity of adverse reactions and health-related quality of life (HQL) assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy and Safety
Keywords
PEGylated Doxorubicin Hydrochloride Liposome Injection, Duomeisu, First-line treatment, Epithelial Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
pegylated liposomal doxorubicin 30 mg/m2, i.v.,d1; carboplatin AUC 5,i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
paclitaxel 175 mg/m2, i.v.,d1; carboplatin AUC 5, i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin
Other Intervention Name(s)
duomeisu
Intervention Description
PLD 30 mg/m2, i.v.,d1; once every 21days
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
zishanchun
Intervention Description
paclitaxel 175 mg/m2, i.v.,d1; once every 21days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
kabo
Intervention Description
carboplatin AUC 5, i.v.,d1; once every 21days,
Primary Outcome Measure Information:
Title
PFS
Description
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
Time Frame
From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 36 months.
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
From date of randomization until the date of death from any cause, or date of last follow-up for patients still alive, assessed up to 36 months
Title
ORR
Description
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment.
Time Frame
From date of randomization until PD or death from any cause, assessed up to 36 months.
Title
DCR
Description
DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
Time Frame
From date of randomization until PD or death from any cause, assessed up to 36 months.
Title
the incidence and severity of adverse reactions
Description
Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.
Time Frame
A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 36 months.
Title
quality of life assessment
Description
according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception.
Time Frame
It will be assessed at baseline and before the administration of drugs at each first day of every two chemotherapy cycles, up to 6 cycles,each cycle is 21 days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75years old; Histopathologically or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer; According to the International Federation of Obstetrics and Gynecology (FIGO), the stage is Ic-IV; Imaging assessment is based on the solid tumor efficacy evaluation standard (RECIST) version 1.1, lesions can be measured, or patients' CA125 assessed according to GCIG criteria; Neoadjuvant chemotherapy can be given to patients with excessive tumor volume or a wide range of lesions, who are not expected to achieve ideal cytoreductions before surgery; ECOG score ≤ 2; Expected survival time ≥ 3 months; LVEF ≥ 50%; Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L; Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or <ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present; The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating; Signed the informed consent. Exclusion Criteria: Patients with low-grade malignant potential ovarian tumors; Patients who had previously received chemotherapy or pelvic and abdominal radiotherapy; Patients planning to receive abdominal or pelvic chemotherapy; The New York Heart Association (NYHA) graded class II heart disease patients (including grade II) previous or current; Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin; Uncontrolled systemic infection requiring anti-infective treatment; Allergies to chemotherapeutic drugs or their excipients or intolerant patients; Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03; Researchers think it is not suitable for enrolling.
Facility Information:
Facility Name
Women's Hospital School Of Medicine Zhejiang University
City
Zhejiang
State/Province
Hangzhou
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer

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