Clinical trial NCT03164980: QoL-Comparison Between Trabectedin/PLD and Pt-based Therapy in Patients With Pt-sensitive Recurrent Ovarian Cancer
Official title: Comparison of Quality of Life (QoL) Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Quality of Life
Ovarian Cancer
Recurrent Ovarian Carcinoma
Keywords: Quality of life
ovarian cancer
platinum sensitive
recurrent
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
Collaborators: name: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
name: PharmaMar
First posted: 2017-05-24
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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 origin)
   * 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 therapy).
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 outcomes:
measure: Difference in Quality of Life (QoL)
timeFrame: 12 month (from baseline to end of treatment)
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 18 month
measure: Overall Survival
timeFrame: through study completion, up to 3 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Berlin
country: Germany
facility: Sankt Gertrauden-Krankenhaus
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Praxis Krebsheilkunde für Frauen
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn Friedensplatz
city: Brandenburg an der Havel
country: Germany
facility: Universitätsklinikum Brandenburg an der Havel
city: Braunschweig
country: Germany
facility: Studien GbR Braunschweig
city: Dessau
country: Germany
facility: Städtisches Klinikum Dessau
city: Dresden
country: Germany
facility: Frauenklinik Carl Gustav Carus
city: Dresden
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest gGmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Krefeld
country: Germany
facility: ZAGO am Helios Klinikum Krefeld
city: Leipzig
country: Germany
facility: Universitätsfrauenklinik Leipzig
city: Mainz
country: Germany
facility: Universitätsklinik der Johannes Gutenberg-Universität Mainz
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
city: Saarbrücken
country: Germany
facility: Caritas Klinikum St. Theresia
city: Saarlouis
country: Germany
facility: Krankenhaus Saarlouis vom DRK
city: Unna
country: Germany
facility: Christliches Klinikum Unna gGmbH
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jalid Sehouli, Prof.
role: PRINCIPAL_INVESTIGATOR
References: