LeiomyosarcomaPhase 2TAULNCT02249702
Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma
A Phase 2 study testing gemcitabine + docetaxel and trabectedin in people with Leiomyosarcoma, run by Mario Negri Institute for Pharmacological Research at 34 sites in Italy.
Trial summary
The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyosarcoma
- What is being tested?
- gemcitabine + docetaxel and trabectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 34 sitesItaly
- Study dates
- Apr 2010to 30 Apr 2017
- Phase
- Phase 2
- 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
- Histologically proven uterine leiomyosarcoma.
- Persistent or locally relapsed and/or metastatic disease.
- At least one previous systemic treatment with an anthracycline ± ifosfamide or gemcitabine ± docetaxel.
- Measurable disease, as defined by RECIST criteria.
- ECOG PS <=2.
- Age >= 18 years.
Show all 12Show fewer
- A minimum of 3 weeks since prior tumor directed therapy
- Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower.
- Adequate haematological function.
- Adequate renal function.
- Adequate liver function.
- Signed informed consent.
Who cannot join
- Prior exposure to Trabectedin.
- Peripheral neuropathy, Grade 2 or higher.
- History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse.
- Known CNS metastases.
- Active viral hepatitis or chronic liver disease.
- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias.
- Active major infection.
- Other serious concomitant illnesses
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Italy34 sites
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
Alessandria
Centro di Riferimento Oncologico
Aviano, Pordenone
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
Presidio Ospedaliero Senatore Antonio Perrino
Brindisi
Fondazione del Piemonte per l'Oncologia
Candiolo, Turin
Azienda Ospedaliera per l'Emergenza Cannizzaro
Catania
Ospedale Sant'Anna
Como
Azienda Ospedaliera S. Croce e Carle
Cuneo
Azienda Ospedaliera Universitaria San Martino - IST
Genoa
Ente Ospedaliero Ospedali Galliera
Genova
Azienda USL 2 Toscana - Nuovo Ospedale San Luca
Lucca
Istituto Clinico Humanitas
Milan
Istituto Europeo di Oncologia
Milan
Istituto Nazionale dei Tumori di Milano
Milan
Istituto Nazionale dei Tumori di Milano
Milan
Azienda ULSS 13 Regione Veneto, Ospedale di Mirano
Mirano, Venice
Azienda Ospedaliera San Gerardo
Monza
Istituto Nazionale Tumori - Fondazione Pascale
Naples
Ospedale Sacro Cuore Don Calabria
Negrar, Verona
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara
Istituto Oncologico Veneto
Padova
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo
Azienda Ospedaliero-Universitaria di Parma
Parma
Policlinico San Matteo
Pavia
Azienda Ospadaliero-Universitaria Pisana
Pisa
Azienda Ospedaliera Regionale San Carlo
Potenza
Azienda Ospedaliera Arcispedale S. Maria Nuova
Reggio Emilia
Policlinico Umberto I
Roma, RM, 00186
Ospedale San Giovanni Calibita Fatebenefratelli
Roma
Policlinico Umberto I - Università Sapienza
Roma
Policlinco Universitario Agostino Gemelli
Rome
Azienda Ospedaliera Ordine Mauriziano
Torino
Azienda Ospedaliero-Universitaria di Torino - Presidio Sant'Anna
Torino
Presidio Sanitario Gradenigo
Torino
About this study
Official title: A Phase II Randomized - Non Comparative - Study on the Activity of Trabectedin or Gemcitabine + Docetaxel in Metastatic or Locally Relapsed Uterine Leiomyosarcoma Pretreated With Conventional Chemotherapy
The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. Patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than one year. Treatment options for recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and 27-53%, respectively. Both these regimens have been increasingly used in the last years also in the adjuvant setting. For relapsed patients other drugs have been tested as single agent but negligible activity was observed.
Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS, activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. Although the response rate did not exceed 10%, T was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies will be performed to identify factors predictive of the activity of T in this specific histotype.
- Conditions
- Leiomyosarcoma
- Being tested
- gemcitabine + docetaxel, trabectedin
- Keywords
- trabectedin, uterine leiomyosarcoma
- Medical subject headings
- Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine + docetaxelDrug
Also called Gemzar, Taxotere
trabectedinDrug
Also called Yondelis
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin | Experimental | Trabectedin 1.3 mg/m2 will be administered via a central venous catheter as a 24-hour infusion on day 1 of 21-days treatment cycles. Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician. Receives: Drug: trabectedin |
| gemcitabine + docetaxel | Active comparator | Gemcitabine 900 mg/m2 will be administered via a central venous catheter on days one and eight over 90 min, followed by docetaxel 75 mg/m2 on day eight iv over 1 h. Gemcitabine+docetaxel treatment is planned for six cycles, unless there is evidence of disease progression, unacceptable toxicity or patient's intolerance or unwillingness to continue treatment, or medical decision by the responsible physician. Patients with continued response after six cycles can receive two additional cycles of combination therapy or continue with Gemcitabine alone. Receives: Drug: gemcitabine + docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free rate at 6-month
Primary objective will be to assess the clinical benefit rate (defined as 6-month progression free rate) with trabectedin in patients with locally relapsed/metastatic uterine leiomyosarcoma pretreated with anthracycline ± ifosfamide and/or gemcitabine ± docetaxel.
Measured: 6-month
Secondary outcomes (1)
best response rate
response rate according to RECIST v1.0 criteria
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startApr 2010
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Angiolo Gadducci, MD, Principal investigator, Azienda Ospedaliero Universitaria Pisana, Pisa, ItalyFederica Grosso, MD, Principal investigator, Azienda Ospedaliera Alessandria, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249702
- Sponsor's protocol ID
- TAUL
- Other IDs
- 2009-016017-24, 2009
- Acronym
- TAUL
- Status last verified
- Dec 2017
- First submitted
- 23 Sep 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized - Non Comparative - Study on the Activity of Trabectedin or Gemcitabine + Docetaxel in Metastatic or Locally Relapsed Uterine Leiomyosarcoma Pretreated With Conventional Chemotherapy
- ClinicalTrials.gov ID
- NCT02249702
- Acronym / sponsor ID
- TAUL / TAUL
- Conditions
- Leiomyosarcoma
- Keywords
- trabectedin, uterine leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- Apr 2010
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. Patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than one year. Treatment options for recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and 27-53%, respectively. Both these regimens have been increasingly used in the last years also in the adjuvant setting. For relapsed patients other drugs have been tested as single agent but negligible activity was observed.
Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS, activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. Although the response rate did not exceed 10%, T was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies will be performed to identify factors predictive of the activity of T in this specific histotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabectedin | Experimental | Drug: trabectedinTrabectedin 1.3 mg/m2 will be administered via a central venous catheter as a 24-hour infusion on day 1 of 21-days treatment cycles. Trabectedin treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician. |
| gemcitabine + docetaxel | Active comparator | Drug: gemcitabine + docetaxelGemcitabine 900 mg/m2 will be administered via a central venous catheter on days one and eight over 90 min, followed by docetaxel 75 mg/m2 on day eight iv over 1 h. Gemcitabine+docetaxel treatment is planned for six cycles, unless there is evidence of disease progression, unacceptable toxicity or patient's intolerance or unwillingness to continue treatment, or medical decision by the responsible physician. Patients with continued response after six cycles can receive two additional cycles of combination therapy or continue with Gemcitabine alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven uterine leiomyosarcoma.
- Persistent or locally relapsed and/or metastatic disease.
- At least one previous systemic treatment with an anthracycline ± ifosfamide or gemcitabine ± docetaxel.
- Measurable disease, as defined by RECIST criteria.
- ECOG PS <=2.
Key exclusion criteria (8 listed)
- Prior exposure to Trabectedin.
- Peripheral neuropathy, Grade 2 or higher.
- History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse.
- Known CNS metastases.
- Active viral hepatitis or chronic liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine + docetaxelAlso: Gemzar, Taxotere | Drug | gemcitabine + docetaxel |
| trabectedinAlso: Yondelis | Drug | Trabectedin |
Primary outcome
progression free rate at 6-month
Time frame: 6-month
Primary objective will be to assess the clinical benefit rate (defined as 6-month progression free rate) with trabectedin in patients with locally relapsed/metastatic uterine leiomyosarcoma pretreated with anthracycline ± ifosfamide and/or gemcitabine ± docetaxel.
1 secondary outcome
best response rate
Time frame: within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angiolo Gadducci, MD principal investigator
Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
Federica Grosso, MD principal investigator
Azienda Ospedaliera Alessandria, Italy
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine + docetaxel and trabectedin in people with Leiomyosarcoma, run by Mario Negri Institute for Pharmacological Research at 34 sites in Italy.
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 12 inclusion and 8 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: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
progression free rate at 6-month (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2017.