- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03794778
Evaluation of PLD Combined With Carboplatin Versus Paclitaxel Plus Carboplatin in the First-line Treatment of Epithelial Ovarian Cancer
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Hangzhou
-
Zhejiang, Hangzhou, China, 310006
- Women's Hospital School of Medicine Zhejiang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
PLD 30 mg/m2, i.v.,d1; once every 21days
Other Names:
carboplatin AUC 5, i.v.,d1; once every 21days,
Other Names:
|
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.
|
carboplatin AUC 5, i.v.,d1; once every 21days,
Other Names:
paclitaxel 175 mg/m2, i.v.,d1; once every 21days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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.
|
From date of randomization until PD or death from any cause, assessed up to 36 months.
|
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.
|
From date of randomization until PD or death from any cause, assessed up to 36 months.
|
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.
|
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.
|
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.
|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Carboplatin
- Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- 20180148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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