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Recurrent Ovarian CarcinomaPhase 3NCT03690739

Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

A Phase 3 study testing Carboplatin, Gemcitabine and Bevacizumab in people with Recurrent Ovarian Carcinoma, run by AGO Research GmbH at 29 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, prospective, randomized, controlled, parallel group, multi-center phase III trial to evaluate the Symptom Benefit Rate of trabectedin/PLD in patients with recurrent ovarian cancer who achieve a stabilization of disease after 3 cycles of platinum-based reinduction therapy and with no clinical… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Ovarian Carcinoma
What is being tested?
Carboplatin, Gemcitabine and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
29 sitesGermany
Study dates
9 Aug 2019to 3 Mar 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females aged ≥ 18 years at time of signing informed consent form.
  • Histologically proven diagnosis of cancer of the ovary, the fallopian tube or primary peritoneal cancer.
  • Measurable or non-measurable disease (according RECIST v1.1) or CA-125 assessable disease (according GCIG criteria) or histologically proven diagnosis of relapse.
  • Platinum-treatment free interval (TFIp) > 6 months prior to cycle 1 day 1 of reinduction therapy.
  • Disease stabilization without remission or progression ac-cording to RECIST or GCIG criteria after three cycles of platinum-based chemotherapy for recurrent disease.
  • Symptomatic disease at time of baseline abdominal/GI symptom scale score >15 (EORTC QLQ-OV28)
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  • Completion of EORTC QLQ-OV28 at Baseline within 7 days prior to treatment start.
  • Patients should have received previously a taxane derivative.
  • ECOG performance status ≤ 2.
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, renal and hepatic function defined as:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9.0 g/dL
  • Serum creatinine ≤1.5 mg/dL (≤ 132.6 µmol/L) or creatinine clearance ≥ 60 mL/min
  • Creatine phosphokinase (CPK) ≤ 2.5 x ULN
  • Serum aspartate aminotransferase (AST, SGOT) or alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN (≤ 5 x ULN in the presence of liver metastases)
  • Alkaline phosphatase (ALP) ≤ 2.5 ULN
  • Serum bilirubin ≤ ULN
  • Albumin ≥ 25 g/l
  • Participation in an informed consent discussion with the appropriate trial-related health care representative, full understanding of the implications and constraints of the protocol, and provision of written informed consent prior to the commencement of the trial-related procedures.
  • Geographically accessibility for treatment and follow-up.
  • For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual inter-course) or use a contraceptive method with a failure rate of < 1 per-centage per year during the treatment period and for at least six months after administration of the last dose of chemo-therapy. A woman is considered to be of childbearing po-tential if she is postmenarcheal, has not reached a post-menopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fal-lopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1 percentage per year in-clude but are not limited to bilateral tubal ligation and/or oc-clusion, male sterilization, and intrauterine devices, and nor-mal and low dose combined oral pill plus male condom or Cerazette (desogestrel) plus male condom. Cerazette is currently the only highly efficacious progesterone based pill. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation meth-ods) and withdrawal are not acceptable methods of contra-ception.

Who cannot join

  • Ovarian tumors of low malignant potential (e.g. borderline tumors).
  • Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Müllerian tumors).
  • Patients with an objective response in terms of a partial or complete remission or alternatively progressive disease ac-cording to RECIST or GCIG criteria after three cycles of platinum-based reinduction chemotherapy.
  • Patients who have received previous radiotherapy for ovarian cancer.
  • History of congestive heart failure (NYHA classification > 2, even if medically con-trolled).
  • History of myocardial infarction within the last six months (documented or by electrocardiogram).
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  • History of atrial or ventricular arrhythmias.
  • Impaired liver function, hyperbilirubinemia, Serum creatinine >1.5 mg/dL or > 132.6 μmol/L or creatinine clearance < 60 mL/min, left ventricular ejection fraction < 45 %.
  • Severe active or uncontrolled infection.
  • Concurrent severe medical problems unrelated to malignancy, which would significantly limit full compliance with the trial or expose the patient to extreme risk or decreased life expectancy.
  • Patients with known hypersensitivity to the active substance or their compounds related to trabectedin or PLD and patients with known hypersensitivity to one of active substances or one of their compounds used in platinum-based chemotherapy as described in the Summaries of Medicinal Products.
  • Patients with potential risks according to contraindication, warnings or interactions of the used chemotherapeutic agents as stated in the SmPCs are not eligible for participation in this trial.
  • Patients with contraindication regarding CT or MRI (only in case of contrast allergy) are excluded.
  • Women of childbearing potential (WOCBP) not using highly effective contraceptive methods.
  • Pregnancy or breast-feeding.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Germany29 sites

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, Bavaria, 63739

  • Hochtaunus-Kliniken

    Bad Homburg

  • Sozialstiftung Bamberg

    Bamberg

  • Evangelisches Krankenhaus Bergisch Gladbach

    Bergisch Gladbach

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsfrauenklinik Bonn

    Bonn

  • Schwerpunktpraxis für Onkologie / Hämatologie

    Bottrop

  • Frauenärzte Casparistraße

    Braunschweig

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Evang. Kliniken Essen-Mitte

    Essen

  • Agaplesion Markus Krankenhaus

    Frankfurt

  • Universitätsmedizin Greifswald

    Greifswald

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg

  • Klinikum Itzehoe

    Itzehoe

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe

  • Klinikum Ludwigsburg

    Ludwigsburg

  • Klinikum Magdeburg

    Magdeburg

  • Katholisches Klinikum Mainz

    Mainz

  • Universitätsfrauenklinik Mannheim

    Mannheim

  • Klinikum Memmingen

    Memmingen

  • Klinikum rechts der Isar

    München

  • Kliniken des Landkreises Neumarkt

    Neumarkt

  • Universitätsklinik für Innere Medizin, Onkologie und Hämatologie

    Oldenburg

  • Klinikum Ernst von Bergmann

    Potsdam

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme)

  • Thüringen Kliniken "Georgius Agricola"

    Saalfeld

  • g.Sund Gyn. Kompetenzzentrum

    Stralsund

  • Kreiskrankenhaus "Johann Kentmann"

    Torgau

  • Helios Dr. Horst Schmidt Kliniken

    Wiesbaden

Other trials in Germany

About this study

Official title: Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer

This is an open-label, prospective, randomized, controlled, parallel group, multi-center phase III trial to evaluate the Symptom Benefit Rate of trabectedin/PLD in patients with recurrent ovarian cancer who achieve a stabilization of disease after 3 cycles of platinum-based reinduction therapy and with no clinical benefit.

Read the detailed description

Approximately 330 patients will be randomized in a 1:1 ration to the treatments specified below:

Arm A - Platinum-based chemotherapy according to investigator's discretion Arm B - Pegylated liposomal doxorubicin 30 mg/m² + Trabectedin 1.1 mg/m² (q3w)

Keywords
Symptom Benefit
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Administration according to investigator's discretion

  • GemcitabineDrug

    Administration according to investigator's discretion

  • BevacizumabDrug

    Administration according to investigator's discretion

  • PLDDrug

    Administration according to investigator's discretion

  • PaclitaxelDrug

    Administration according to investigator's discretion

  • PLDDrug

    Administration 30 mg/m² q21

  • TrabectedinDrug

    Administration 1.1 mg/m² q21

  • CisplatinDrug

    Administration according to investigator's discretion

Study groups in NCT03690739
Study groupRoleWhat they receive
platinum-based chemotherapyActive comparatorAccording to the investigator's discretion
Receives: Drug: Carboplatin; Drug: Gemcitabine; Drug: Bevacizumab; Drug: PLD; Drug: Paclitaxel; Drug: Cisplatin
PLD + TrabectedinActive comparatorPLD 30 mg/m² + Trabectedin 1.1 mg/m² q21
Receives: Drug: PLD; Drug: Trabectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom Benefit Rate

    Proportion of patients achieving a symptom benefit defined as an at least 10-point improvement according to EORTC QLQ-OV28; EORTC QLQ-OV28 is a questionnaire regarding Quality of Life specialized for Ovarian Cancer with points from 1 till 4 for each of the 28 questions (1=not at all, 2=a little, 3=quite a bit, 4=very much). Points will be summarized.

    Measured: from Baseline to 8 or 9 weeks after randomization, assessed at each visit

Secondary outcomes (6)

  1. Time until definitive deterioration (TUDD )

    TUDD is defined as time from baseline until the first decrease in EORTC QLQ-C30 score ≥ 10 points (or 20 points) as compared at baseline; EORTC QLQ-C30 is a questionnaire regarding Quality of Life specialized for Cancer with points for each of the 30 questions (1=not at all, 2=a little, 3=quite a bit, 4=very much). Points will be summarized.

    Measured: from Baseline until 24 months after randomization, assessed up to 54 months at each visit

  2. Progression-free survival (PFS)

    Progressive disease is based on investigator assessment using RECIST v1.1

    Measured: PFS is defined as time from randomization to disease progression according to RECIST v1.1, to death from any cause or to start of a new treatment (whichever occurs first), assessed up to 54 months

  3. Progression-free survival (PFS) rate at 6 months

    Progressive disease is based on investigator assessment using RECIST v1.1

    Measured: PFS is defined as time from randomization to disease progression according to RECIST v1.1, to death from any cause or to start of a new treatment (whichever occurs first) after six months

  4. Response Rate (RR)

    RR is based on investigator assessment using RECIST v1.1

    Measured: from randomization until patients achieving complete response (CR) or partial response (PR) as best overall response, assessed up to 54 months

  5. Global Health Status

    based on Quality of Life; EORTC QLQ-C30 and EORTC QLQ-OV 28 are questionnaires for Quality of Life with points for each of the 30 or 28 questions (1=not at all, 2=a little, 3=quite a bit, 4=very much). Points will be summarized.

    Measured: from baseline to end of treatment, assessed up to 54 months at each visit

  6. Overall Survival (OS)

    regular patient contact during the trila regarding life status

    Measured: OS is defined as the time from randomization to death from any cause, assessed up to 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2018
  2. Study start9 Aug 2019
  3. Primary completion3 Mar 2021
  4. Study completion3 Mar 2021

Why it stopped: Insufficient Recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690739
Sponsor's protocol ID
AGO-OVAR 2.32
Status last verified
Feb 2022
First submitted
26 Sep 2018
Last updated
24 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Gemcitabine and Bevacizumab in people with Recurrent Ovarian Carcinoma, run by AGO Research GmbH at 29 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient Recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Benefit Rate (time frame: from Baseline to 8 or 9 weeks after randomization, assessed at each visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03690739.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.

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