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

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ClinicalTrials.gov Identifier: NCT03164980
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : August 31, 2021
Sponsor:
Collaborators:
Institute of Clinical Cancer Research (IKF)
PharmaMar
Information provided by (Responsible Party):
North Eastern German Society of Gynaecological Oncology

Tracking Information
First Submitted Date  ICMJE May 18, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date August 31, 2021
Actual Study Start Date  ICMJE November 27, 2017
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
observation of change in QoL [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
observation of change in QoL [ Time Frame: 3 month ]
QoL change from baseline (C1 D1) to after 3 months (± 2 week) or at progression, whichever occurs first. (EORTC QLQ-C30, EORTC QLQ-ov28)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • Difference in QoL [ Time Frame: 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).
  • Progression-free survival [ Time Frame: 18 month ]
  • Overall survival [ Time Frame: 18 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • Difference in QoL [ Time Frame: 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, EORTC QLQ-ov28).
  • Progression-free survival [ Time Frame: 18 month ]
  • Overall survival [ Time Frame: 18 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of QoL Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Quality of Life
  • Ovarian Cancer
  • Recurrent Ovarian Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Arm A
    PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
    Intervention: Drug: Trabectidin (Yondelis)
  • 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.
    Intervention: Drug: Trabectidin (Yondelis)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)
204
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
206
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annika Stürzebecher, Dr. +49 30 403 68 65 41 annika.stuerzebecher@noggo.de
Contact: Maren Keller, Dr. +49 30 403 68 65 32 maren.keller@noggo.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164980
Other Study ID Numbers  ICMJE NOGGO S16/COMPASS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party North Eastern German Society of Gynaecological Oncology
Study Sponsor  ICMJE North Eastern German Society of Gynaecological Oncology
Collaborators  ICMJE
  • Institute of Clinical Cancer Research (IKF)
  • PharmaMar
Investigators  ICMJE
Principal Investigator: Jalid Sehouli, Prof. Charite University, Berlin, Germany
PRS Account North Eastern German Society of Gynaecological Oncology
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP