An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer (Renaissance)

S

Suriya Yessentayeva

Status

Unknown

Conditions

Ovarian Cancer

Treatments

Drug: Trabectedin + PLD

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03446495
R279741OVC4001

Details and patient eligibility

About

This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age>18
  • Histologically proven epithelial ovarian cancer
  • ECOG 0-1
  • Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
  • With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
  • Prior treatment with 1 or more chemotherapy regimen

Exclusion criteria

  • Platinum resistant disease: PFI < 6 months (progression within six months after first-line platinum-based chemotherapy)
  • Unwilling or unable to have a central venous catheter
  • Patients with hepatic impairment (Patients with elevated bilirubin)
  • Patients with renal impairment (Patients with serum creatinine >1.5 mg/dL)
  • Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
  • Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)
  • AIDS-related Kaposi's sarcoma
  • Lactation or pregnancy

Trial design

60 participants in 1 patient group

Trabectedin + PLD
Description:
Trabectedin + PLD according to SmPC
Treatment:
Drug: Trabectedin + PLD

Trial contacts and locations

9

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Central trial contact

Suriya Yessentaeva, PhD

Data sourced from clinicaltrials.gov

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