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

NCT03794778 | Unknown Phase 4 DMC

• 1 other identifier: 20180148
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety

Keywords

PEGylated Doxorubicin Hydrochloride Liposome Injection; Duomeisu; First-line treatment; Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (5)

• OS

  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

  From date of randomization until PD or death from any cause, assessed up to 36 months.

• DCR

  From date of randomization until PD or death from any cause, assessed up to 36 months.

• the incidence and severity of adverse reactions

  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

  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.

Study Arms (2)

study group

EXPERIMENTAL

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; Drug: Carboplatin

chemotherapy

ACTIVE COMPARATOR

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; Drug: Carboplatin

Interventions

pegylated liposomal doxorubicin DRUG

PLD 30 mg/m2, i.v.,d1; once every 21days

Also known as: duomeisu

study group

paclitaxel DRUG

paclitaxel 175 mg/m2, i.v.,d1; once every 21days

Also known as: zishanchun

chemotherapy

Carboplatin DRUG

carboplatin AUC 5, i.v.,d1; once every 21days,

Also known as: kabo

chemotherapy; study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Zhejiang, Hangzhou, 310006, China

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

liposomal doxorubicin; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Women's Hospital School Of Medicine Zhejiang University

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 7, 2019
• Study Start: March 19, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)