Status:
COMPLETED
Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
PharmaMar
Conditions:
Leiomyosarcoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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%. Patients with metasta...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT02249702
Start Date
April 1 2010
End Date
April 30 2017
Last Update
December 6 2017
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro di Riferimento Oncologico
Aviano, Pordenone, Italy
2
Policlinico Umberto I
Roma, RM, Italy, 00186
3
Fondazione del Piemonte per l'Oncologia
Candiolo, Turin, Italy
4
Azienda ULSS 13 Regione Veneto, Ospedale di Mirano
Mirano, Venice, Italy