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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Ovarian Cancer; Recurrent Ovarian Carcinoma
• Intervention / Treatment: Drug: Trabectidin (Yondelis)

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Annika Stürzebecher, Dr.; Phone Number: +49 30 403 68 65 41; Email: annika.stuerzebecher@noggo.de
• Study Contact Backup: Name: Maren Keller, Dr.; Phone Number: +49 30 403 68 65 32; Email: maren.keller@noggo.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Berlin, Germany, 10713
    • Sankt Gertrauden-Krankenhaus
  • Berlin, Germany, 13597
    • Praxis Krebsheilkunde für Frauen
  • Bonn, Germany, 53111
    • Medizinisches Zentrum Bonn Friedensplatz
  • Brandenburg an der Havel, Germany, 14770
    • Universitätsklinikum Brandenburg an der Havel
  • Braunschweig, Germany, 38100
    • Studien GbR Braunschweig
  • Dessau-Roßlau, Germany, 06847
    • Städtisches Klinikum Dessau
  • Dresden, Germany, 01307
    • Onkologische Schwerpunktpraxis
  • Dresden, Germany, 01307
    • Frauenklinik Carl Gustav Carus
  • Frankfurt, Germany, 60488
    • Krankenhaus Nordwest gGmbH
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Krefeld, Germany, 47805
    • ZAGO am Helios Klinikum Krefeld
  • Leipzig, Germany, 04103
    • Universitätsfrauenklinik Leipzig
  • Mainz, Germany, 55131
    • Universitätsklinik der Johannes Gutenberg-Universität Mainz
  • Neuruppin, Germany, 16816
    • Ruppiner Kliniken GmbH
  • Offenbach, Germany, 63069
    • Sana Klinikum Offenbach
  • Rostock, Germany, 18059
    • Klinikum Südstadt Rostock
  • Saarbrücken, Germany, 66113
    • Caritas Klinikum St. Theresia
  • Saarlouis, Germany, 66740
    • Krankenhaus Saarlouis vom DRK
  • Unna, Germany, 59423
    • Christliches Klinikum Unna gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
observation of change in QoL	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)	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in QoL	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).	12 month
Progression-free survival		18 month
Overall survival		18 month

Collaborators and Investigators

• Sponsor: North Eastern German Society of Gynaecological Oncology
• Collaborators: PharmaMar; Frankfurter Institut für Klinische Krebsforschung IKF GmbH
• Investigators: Principal Investigator: Jalid Sehouli, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; ovarian cancer; recurrent; platinum sensitive
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hypersensitivity; Recurrence; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Trabectedin
• Other Study ID Numbers: NOGGO S16/COMPASS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No