Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas (NCT01426633) | Clinical Trial Compass
CompletedPhase 1
Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas
Germany5 participantsStarted 2011-11
Plain-language summary
L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events. The aim of the present phase I study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in L-sarcomas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)
* Measurable disease according to RECIST 1.1
* Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging
* Any prior treatment possible
* Age \>= 18 years
* WHO PS =\< 1
* Effective contraception during study medication and up to 3 months from treatment discontinuation
* Signed informed consent form
Exclusion Criteria:
* Surgical intervention \< 4 weeks
* Pregnancy or lactation
* Known allergic reaction to trabectedin or gemcitabine or one of their components
* The following laboratory values:
Absolute neutrophil count \< 1.5 x 103/mm3 Platelets \< 100.000/mm3 Hb \< 9 g/dL Serum creatinine \>= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK \> 2.5 x ULN Total bilirubin \> 1 x ULN except in the case of Gilbert's syndrome
* Participation in another study (four weeks before and during the study)
* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the maximum tolerated dose (MTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma.