Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer

NCT03335241 | Unknown Phase 2 DMC

• 1 other identifier: 308-2016-03-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Fludarabine; Pegylated Liposomal Doxorubicin; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD

  Up to four years

Secondary Outcomes (1)

• Objective response rate

  Up to four years

Other Outcomes (1)

• Frequency and severity of adverse effects as defined by CTCAE version 4.0

  30 days after last dose

Study Arms (2)

Arm 1: Fludarabine and Pegylated liposomal doxorubicin

EXPERIMENTAL

Drug: Fludarabine and Pegylated liposomal doxorubicin

Arm 2: Pegylated liposomal doxorubicin

ACTIVE COMPARATOR

Drug: Pegylated liposomal doxorubicin

Interventions

Fludarabine and Pegylated liposomal doxorubicin DRUG

Fludarabine 25mg/m2 iv on days d1-d3 of each 4-week cycle Pegylated liposomal doxorubicin 30mg/m2 iv every 4 weeks

Arm 1: Fludarabine and Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin DRUG

Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks

Arm 2: Pegylated liposomal doxorubicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
• Platinum resistant or refractory ovarian cancer
• At least treated with one line of platinum-based chemotherapy
• Female, age ≥18 years and ≤70 years, signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
• Patients must have a life expectancy of at least 3 months.
• Patients must have adequate organ function as defined by the following criteria:
• White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.0 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 80 x 10\^9/L
• Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN
• Serum creatinine ≤ 1 x ULN
• Symptomatic central nervous system (CNS) metastasis
• Has known allergies to any of the excipients.
• Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin
• LVEF (left ventricular ejection fraction) \<50%

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fludarabine; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

Central Study Contacts

Jundong Li

CONTACT

+86-20-87343104; lijd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 7, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)