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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Universitätsklinikum AachenAachenGermany52074
2Gyn-onkologische SchwerpunktpraxisBerlinGermany10317
3Sankt Gertrauden-KrankenhausBerlinGermany10713
4Charité - Universitätsmedizin Berlin, Campus Virchow KlinikumBerlinGermany13353
5Praxis Krebsheilkunde für FrauenBerlinGermany13597
6Medizinisches Zentrum Bonn FriedensplatzBonnGermany53111
7Universitätsklinikum Brandenburg an der HavelBrandenburg an der HavelGermany14770
8Studien GbR BraunschweigBraunschweigGermany38100
9Städtisches Klinikum DessauDessau-RoßlauGermany06847
10Onkologisches Zentrum DonauwörthDonauwörthGermany86609
11Frauenklinik Carl Gustav CarusDresdenGermany01307
12Onkologische SchwerpunktpraxisDresdenGermany01307
13Kaiserswerther DiakonieDüsseldorfGermany40489
14Universitätsklinikum EssenEssenGermany45147
15Krankenhaus Nordwest gGmbHFrankfurtGermany60488
16Universitätsklinikum FreiburgFreiburgGermany79106
17GemeinschaftspraxisFürthGermany90766
18St. Vincentius-Diakonissen-Kliniken g AGKarlsruheGermany76135
19ZAGO am Helios Klinikum KrefeldKrefeldGermany47805
20Universitätsfrauenklinik LeipzigLeipzigGermany04103
21Klinik der Otto-von-Guericke-Universität MagdeburgMagdeburgGermany39108
22Universitätsklinik der Johannes Gutenberg-Universität MainzMainzGermany55131
23Universitätsmedizin MannheimMannheimGermany68167
24Ruppiner Kliniken GmbHNeuruppinGermany16816
25Sana Klinikum OffenbachOffenbachGermany63069
26St. Vincenz Krankenhaus GmbHPaderbornGermany33098
27Klinikum Südstadt RostockRostockGermany18059
28Caritas Klinikum St. TheresiaSaarbrückenGermany66113
29Krankenhaus Saarlouis vom DRKSaarlouisGermany66740
30Marienhospital StuttgartStuttgartGermany70199
31Christliches Klinikum Unna gGmbHUnnaGermany59423
32Helios Dr. Horst Schmidt Kliniken WiesbadenWiesbadenGermany65199
33amO WolfsburgWolfsburgGermany38440

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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022