QoL-Comparison Between Trabectedin/PLD and Pt-based Therapy in Patients With Pt-sensitive Recurrent Ovarian Cancer

NCT03164980 | Terminated Phase 4 Results

• 1 other identifier: NOGGO S16/COMPASS
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 21

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.

Conditions

Quality of Life; Ovarian Cancer; Recurrent Ovarian Carcinoma

Keywords

Quality of life; ovarian cancer; platinum sensitive; recurrent

Outcome Measures

Primary Outcomes (1)

• Difference in Quality of Life (QoL)

  The difference in QoL is defined as change of the mean score of the Trial Outcome Index (TOI) from baseline (TOI at randomization) compared to end of treatment (TOI at EOT) and is calculated as follows: Difference TOI = TOI at EOT - TOI at baseline. 1. equals to 0 meaning no change in quality of life at EOT compared to baseline 2. \>0 meaning a detoriated quality of life at EOT compared to baseline. (The higher the number, the higher the detoriation.) 3. \<0 meaning an improved quality of life at EOT compared to baseline. (The lower the number, the higher the improvement.) TOI is calculated as mean of subscores concerning functional scales (e.g. physical function) and symptomal scales (e.g. body image, chemotherapy side effects, attitude to disease/treatment). Scores of each scale are transformed and ranges between 0-100. High scores for functional scales and symptomal scales meaning a low level of functioning and a high level of symptomatology/problems, respectively.

  12 month (from baseline to end of treatment)

Secondary Outcomes (2)

• Progression-free Survival

  18 month

• Overall Survival

  through study completion, up to 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.

Drug: Trabectidin (Yondelis)

Arm B

EXPERIMENTAL

* 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.

Drug: Trabectidin (Yondelis)

Interventions

Trabectidin (Yondelis) DRUG

To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel

Arm A; Arm B

Eligibility Criteria

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

You may qualify if:

• Women aged ≥ 18 years
• Patients with histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer who received ≥1 prior chemotherapy
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• 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

You may not qualify if:

• Only malignancies, which influence the prognosis
• Any unstable or serious concurrent condition (e.g. active infection requiring systemic therapy).
• Chemotherapy or radiation therapy or tumor embolization within 2 weeks prior to the first dose of study drug or planned during study participation.
• Patients who have refractory disease. Refractory disease is defined if relapse occurs \<4 months after beginning of platin-containing therapy.
• Hypersensitivity to the active substance or to any of the excipients of study drug
• 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.
• 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.
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
• 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.
• Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
• Patients who are depending on the sponsor/CRO or investigational site as well as on the investigator.
• Pregnancy or lactation period, or planning to become pregnant within 7 months after the end of treatment.

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: lead
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: collaborator
• PharmaMar: collaborator

Study Sites (21)

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Sankt Gertrauden-Krankenhaus

Berlin, 10713, Germany

Location

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Praxis Krebsheilkunde für Frauen

Berlin, 13597, Germany

Location

Medizinisches Zentrum Bonn Friedensplatz

Bonn, 53111, Germany

Location

Universitätsklinikum Brandenburg an der Havel

Brandenburg, 14770, Germany

Location

Studien GbR Braunschweig

Braunschweig, 38100, Germany

Location

Städtisches Klinikum Dessau

Dessau, 06847, Germany

Location

Frauenklinik Carl Gustav Carus

Dresden, 01307, Germany

Location

Onkologische Schwerpunktpraxis

Dresden, 01307, Germany

Location

Krankenhaus Nordwest gGmbH

Frankfurt, 60488, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

ZAGO am Helios Klinikum Krefeld

Krefeld, 47805, Germany

Location

Universitätsfrauenklinik Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinik der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Ruppiner Kliniken GmbH

Neuruppin, 16816, Germany

Location

Sana Klinikum Offenbach

Offenbach, 63069, Germany

Location

Klinikum Südstadt Rostock

Rostock, 18059, Germany

Location

Caritas Klinikum St. Theresia

Saarbrücken, 66113, Germany

Location

Krankenhaus Saarlouis vom DRK

Saarlouis, 66740, Germany

Location

Christliches Klinikum Unna gGmbH

Unna, 59423, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

Trabectedin

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Due to slow recruitment of the trial, the recruitment was prematurely terminated after randomization of the 89th patient.

Results Point of Contact

• Title: Jasmin Yamamoto
• Organization: NOGGO e.V.

jasmin.yamamoto@noggo.de

+49 30 4036865 32

Study Officials

• Jalid Sehouli, Prof.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 24, 2017
• Study Start: February 1, 2018
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Locations

DE (21)