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

Sponsor
North Eastern German Society of Gynaecological Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03164980
Collaborator
Institute of Clinical Cancer Research (IKF) (Other), PharmaMar (Industry)
204
Enrollment
33
Locations
2
Arms
75.1
Anticipated Duration (Months)
6.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trabectidin (Yondelis)
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 27, 2017
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

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

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

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

Outcome Measures

Primary Outcome Measures

  1. observation of change in QoL [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 Measures

  1. Difference in QoL [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 [18 month]

  3. Overall survival [18 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

  1. 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.

  2. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiogram

  3. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Aachen Aachen Germany 52074
2 Gyn-onkologische Schwerpunktpraxis Berlin Germany 10317
3 Sankt Gertrauden-Krankenhaus Berlin Germany 10713
4 Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum Berlin Germany 13353
5 Praxis Krebsheilkunde für Frauen Berlin Germany 13597
6 Medizinisches Zentrum Bonn Friedensplatz Bonn Germany 53111
7 Universitätsklinikum Brandenburg an der Havel Brandenburg an der Havel Germany 14770
8 Studien GbR Braunschweig Braunschweig Germany 38100
9 Städtisches Klinikum Dessau Dessau-Roßlau Germany 06847
10 Onkologisches Zentrum Donauwörth Donauwörth Germany 86609
11 Frauenklinik Carl Gustav Carus Dresden Germany 01307
12 Onkologische Schwerpunktpraxis Dresden Germany 01307
13 Kaiserswerther Diakonie Düsseldorf Germany 40489
14 Universitätsklinikum Essen Essen Germany 45147
15 Krankenhaus Nordwest gGmbH Frankfurt Germany 60488
16 Universitätsklinikum Freiburg Freiburg Germany 79106
17 Gemeinschaftspraxis Fürth Germany 90766
18 St. Vincentius-Diakonissen-Kliniken g AG Karlsruhe Germany 76135
19 ZAGO am Helios Klinikum Krefeld Krefeld Germany 47805
20 Universitätsfrauenklinik Leipzig Leipzig Germany 04103
21 Klinik der Otto-von-Guericke-Universität Magdeburg Magdeburg Germany 39108
22 Universitätsklinik der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
23 Universitätsmedizin Mannheim Mannheim Germany 68167
24 Ruppiner Kliniken GmbH Neuruppin Germany 16816
25 Sana Klinikum Offenbach Offenbach Germany 63069
26 St. Vincenz Krankenhaus GmbH Paderborn Germany 33098
27 Klinikum Südstadt Rostock Rostock Germany 18059
28 Caritas Klinikum St. Theresia Saarbrücken Germany 66113
29 Krankenhaus Saarlouis vom DRK Saarlouis Germany 66740
30 Marienhospital Stuttgart Stuttgart Germany 70199
31 Christliches Klinikum Unna gGmbH Unna Germany 59423
32 Helios Dr. Horst Schmidt Kliniken Wiesbaden Wiesbaden Germany 65199
33 amO Wolfsburg Wolfsburg Germany 38440

Sponsors and Collaborators

  • North Eastern German Society of Gynaecological Oncology
  • Institute of Clinical Cancer Research (IKF)
  • PharmaMar

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
North Eastern German Society of Gynaecological Oncology
ClinicalTrials.gov Identifier:
NCT03164980
Other Study ID Numbers:
  • NOGGO S16/COMPASS
First Posted:
May 24, 2017
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by North Eastern German Society of Gynaecological Oncology
Quality of life
ovarian cancer
platinum sensitive
recurrent
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Recurrence
Trabectedin

Study Results

No Results Posted as of Apr 6, 2022