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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164980
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : April 6, 2022
Sponsor:
Collaborators:
Institute of Clinical Cancer Research (IKF)
PharmaMar
Information provided by (Responsible Party):
North Eastern German Society of Gynaecological Oncology

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
Quality of Life Ovarian Cancer Recurrent Ovarian Carcinoma 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 27, 2017
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024


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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).

  2. Progression-free survival [ Time Frame: 18 month ]
  3. Overall survival [ Time Frame: 18 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164980


Contacts
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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

Locations
Show Show 33 study locations
Sponsors and Collaborators
North Eastern German Society of Gynaecological Oncology
Institute of Clinical Cancer Research (IKF)
PharmaMar
Investigators
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Principal Investigator: Jalid Sehouli, Prof. Charite University, Berlin, Germany
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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    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents