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Imfinzi NSCLC
Imfinzi NSCLC

Comparison of QoL Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer



November 2017

Letztes Update:

Trabectidin (Yondelis)

Indikation (Clinical Trials):
Ovarian Neoplasms, Hypersensitivity, Carcinoma, Ovarian Epithelial


Erwachsene (18+)

Phase 4

North Eastern German Society of Gynaecological Oncology

Institute of Clinical Cancer Research (IKF), PharmaMar,


Jalid Sehouli, Prof.
Principal Investigator
Charite University, Berlin, Germany


(3 von 25)

Darmkrebszentrum Sankt Gertrauden-Krankenhaus, Berlin
Paretzer Straße 12
10713 Berlin
DeutschlandRekrutierend» Google-Maps
Michaela Platzer
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Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
13353 Berlin
GermanyRekrutierend» Google-Maps
Isil Yalcinkaya
Phone: +(49)30450564404
» Ansprechpartner anzeigen
Frauenklinik Carl Gustav Carus
01307 Dresden
GermanyRekrutierend» Google-Maps
Christine Griebsch
Phone: +(49)3514584202
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Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandRekrutierend» Google-Maps
Katharina Denzel
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ZAGO am Helios Klinikum Krefeld
47805 Krefeld
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinik der Johannes Gutenberg-Universität Mainz
55131 Mainz
GermanyRekrutierend» Google-Maps
Martina Seehase
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Gynäkologisches Krebszentrum Marienhospital Stuttgart
Böheimstraße 37
70199 Stuttgart
DeutschlandRekrutierend» Google-Maps
Jessika Strentzsch
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Helios Dr. Horst Schmidt Kliniken Wiesbaden
65199 Wiesbaden
GermanyRekrutierend» Google-Maps
Heike Busse
Phone: ++49 611 43 3234
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Alle anzeigen


Detailed Description:

This is a multicenter, randomized, controlled, open-label study including patients with

recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.

The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD

with other standard platinum-based chemotherapy in platinum-sensitive disease.

Patients with recurrent, platinum-sensitive, ovarian, fallopian tube and peritoneal cancer

will be stratified according to surgery for relapse (R0 vs. R1/2 resection) vs. no surgery in

the same setting and age (< 75 years vs. ≥ 75 years), and randomized 1:1 to receive either

trabectedin/PLD (Arm A) or one of 3 platinum-based standard therapies without bevacizumab

(Arm B, "other standard therapy"). In case of randomization to "other standard therapy", the

investigator has the choice between carboplatin/PLD, carboplatin/gemcitabine and

carboplatin/paclitaxel. Patients in both treatment arms will receive chemotherapy up for 6

cycles or until disease progression (PD), unacceptable toxicities or patient's wish to stop

therapy, whichever occurs first.


Inclusion criteria

1. Women aged ≥ 18 years

2. Patients with histologically confirmed diagnosis of epithelial ovarian cancer, primary

peritoneal carcinoma or fallopian tube cancer who received ≥1 prior chemotherapy

3. Patients must be eligible for platin-containing therapy; Patient is defined as

platin-sensitive when considered for platin-containing therapy by the investigator.

The time frame from end of prior therapy until disease progression alone is not

pivotal for study participation. Patients without a platin-containing regimen in the

previous line who are also eligible for platin-containing regime are also appropriate

for participation

4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

5. Adequate baseline organ function as defined as

- Leucocytes > 3.0 x 109/l

- Platelet count > 100 x 109/l

- Absolute neutrophil count (ANC) ≥1500/mm3

- Haemoglobin ≥ 9 g/dl

- Alkaline Phosphatase (AP) ≤ 2.5 × ULN (consider hepatic isoenzymes 5 nucleotidase

or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in


- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN

- Creatinine-Clearance ≥ 60 ml/min (MDRD formula or Cockroft & Gault formula)

- Serum creatinine ≤ 1.5 mg/dl

- Creatine phosphokinase (CPK) ≤ 2.5 × ULN

- Total bilirubin < ULN

6. Women of childbearing potential should use contraceptives or abstain from heterosexual

activity for the course of the study through 6 months after the last dose of study

medication or be surgically sterile.

7. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50%

as determined by echocardiogram

8. Patients must provide written informed consent prior to performance of study specific

procedures or assessments, and must be willing to comply with treatment and follow up

assessments and procedures.

Exclusion criteria

1. Only malignancies, which influence the prognosis

2. Any unstable or serious concurrent condition (e.g. active infection requiring systemic


3. Chemotherapy or radiation therapy or tumor embolization within 2 weeks prior to the

first dose of study drug or planned during study participation.

4. Patients who have refractory disease. Refractory disease is defined if relapse occurs

<4 months after beginning of platin-containing therapy.

5. Hypersensitivity to the active substance or to any of the excipients of study drug

6. Findings from ECG and/or assessment of LVEF which indicate an anthracycline-related

cardiotoxic process which contradicts administration of liposomal doxorubicin in

accordance with the requirements of the SmPC of PLD.

7. Biological therapy, immunotherapy, hormonal therapy or treatment with an

investigational agent within 14 days (for bevacizumab, 30 days) prior to the first

dose of study drug.

8. Any condition that is unstable or could jeopardize the safety of the patient and their

compliance in the study

9. Participation in another clinical study with experimental therapy within the 30 days

before start of and during treatment. Participation in a non-interventional study

should be discussed with sponsor and NC beforehand.

10. Patients in a closed institution according to an authority or court decision (AMG §

40, Abs. 1 No. 4)

11. Patients who are depending on the sponsor/CRO or investigational site as well as on

the investigator.

12. Pregnancy or lactation period, or planning to become pregnant within 7 months after

the end of treatment.


Primary outcome:

1. observation of change in QoL (Time Frame - 3 month):
QoL change from baseline (C1 D1) to after 3 months (± 2 week) or at progression, whichever occurs first. (EORTC QLQ-C30 in combination with EORTC QLQ-ov28)

Secondary outcome:

1. Difference in QoL (Time Frame - 12 month):
measured at day one of every treatment cycle, at the end of the treatment and after 6 and 12 month (follow up) (EORTC QLQ-C30 in combination with EORTC QLQ-ov28).

2. Progression-free survival (Time Frame - 18 month)

3. Overall survival (Time Frame - 18 month)


  • Experimental: Arm A
    PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
  • Experimental: Arm B
    Carboplatin/PLD Carboplatin/Gemcitabine Carboplatin/Paclitaxel Patients will be treated for 6 cycles or until PD, unacceptable toxicity or patient's wish to discontinue, whichever occurs first.

Geprüfte Regime

  • Trabectidin (Yondelis):
    To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel


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