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

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ClinicalTrials.gov Identifier: NCT03794778
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Xing Xie, Women's Hospital School Of Medicine Zhejiang University

Brief Summary:
This is a randomized, multicenter, open, controlled Post-Marketing Study. 336 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.

Condition or disease Intervention/treatment Phase
Efficacy and Safety Drug: pegylated liposomal doxorubicin Drug: paclitaxel Drug: Carboplatin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2024


Arm Intervention/treatment
Experimental: study group
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.
Drug: pegylated liposomal doxorubicin
PLD 30 mg/m2, i.v.,d1; once every 21days
Other Name: duomeisu

Drug: Carboplatin
carboplatin AUC 5, i.v.,d1; once every 21days,
Other Name: kabo

Active Comparator: chemotherapy
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.
Drug: paclitaxel
paclitaxel 175 mg/m2, i.v.,d1; once every 21days
Other Name: zishanchun

Drug: Carboplatin
carboplatin AUC 5, i.v.,d1; once every 21days,
Other Name: kabo




Primary Outcome Measures :
  1. PFS [ 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. ]
    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 :
  1. OS [ 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 ]
    overall survival

  2. ORR [ Time Frame: From date of randomization until PD or death from any cause, assessed up to 36 months. ]
    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.

  3. DCR [ Time Frame: From date of randomization until PD or death from any cause, assessed up to 36 months. ]
    DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.

  4. the incidence and severity of adverse reactions [ 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. ]
    Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.

  5. quality of life assessment [ 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. ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT03794778


Locations
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China, Zhejiang
Weiguo Lv
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University

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Responsible Party: Xing Xie, Dean of Women's Hospital School Of Medicine Zhejiang University, Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT03794778     History of Changes
Other Study ID Numbers: 20180148
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Xing Xie, Women's Hospital School Of Medicine Zhejiang University:
PEGylated Doxorubicin Hydrochloride Liposome Injection
Duomeisu
First-line treatment
Epithelial Ovarian Cancer

Additional relevant MeSH terms:
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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
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