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

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Active, not recruiting; Phase 4

Conditions: Efficacy and Safety

Treatments: Drug: pegylated liposomal doxorubicin; Drug: Carboplatin; Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03794778

20180148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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396 participants in 2 patient groups

study group

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: pegylated liposomal doxorubicin

chemotherapy

Active Comparator group

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.

Treatment:

Drug: paclitaxel

Drug: Carboplatin