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

NCT ID: NCT03164980

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2023-08-08

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.

Conditions

Quality of Life; Ovarian Cancer; Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: EXPERIMENTAL

Trabectidin (Yondelis)

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Trabectidin (Yondelis)

Intervention Type: DRUG

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

Interventions

Trabectidin (Yondelis)

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North Eastern German Society of Gynaecological Oncology

OTHER

Sponsor Role: lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

Sponsor Role: collaborator

PharmaMar

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jalid Sehouli, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Universitätsklinikum Aachen

Aachen, , Germany

Sankt Gertrauden-Krankenhaus

Berlin, , Germany

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, , Germany

Praxis Krebsheilkunde für Frauen

Berlin, , Germany

Medizinisches Zentrum Bonn Friedensplatz

Bonn, , Germany

Universitätsklinikum Brandenburg an der Havel

Brandenburg, , Germany

Studien GbR Braunschweig

Braunschweig, , Germany

Städtisches Klinikum Dessau

Dessau, , Germany

Frauenklinik Carl Gustav Carus

Dresden, , Germany

Onkologische Schwerpunktpraxis

Dresden, , Germany

Krankenhaus Nordwest gGmbH

Frankfurt, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

ZAGO am Helios Klinikum Krefeld

Krefeld, , Germany

Universitätsfrauenklinik Leipzig

Leipzig, , Germany

Universitätsklinik der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Ruppiner Kliniken GmbH

Neuruppin, , Germany

Sana Klinikum Offenbach

Offenbach, , Germany

Klinikum Südstadt Rostock

Rostock, , Germany

Caritas Klinikum St. Theresia

Saarbrücken, , Germany

Krankenhaus Saarlouis vom DRK

Saarlouis, , Germany

Christliches Klinikum Unna gGmbH

Unna, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NOGGO S16/COMPASS

Identifier Type: -

Identifier Source: org_study_id