Clinical trial · Interventional
Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
NCT02993705CI-TRIAL-00053525MITO 26completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinosarcoma, Ovarian | Ovarian Carcinosarcoma | ONTOLOGY_EXACT | 0.98 |
| Carcinosarcomas Uterine | Carcinosarcoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trabectedin
- description
- Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
- interventionNames
- Drug: Trabectedin
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- three years
- description
- The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.
Secondary outcomes (4)
- measure
- Duration of response
- timeFrame
- three years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy * No more than 2 previous chemotherapy lines * PS 0-2 (ECOG) * Age\> 18 * Measurable disease * Life expectancy of at least 3 months * Adequate organ functions: * Hematopoietic; Absolute neutrophil count ≥ 1,500/mm\^3; Platelet count ≥ 100,000/mm\^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)\*; Protocol Version 1.0\_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times ULN\*; Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 3 times ULN if liver metastases are present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN Serum Albumin \>3.0 g/dL * Previous Brachytherapy treatment for uterine carcinosarcoma is allowed * No other invasive malignancy within the past 3 years except non-melanoma skin cancer * Written Informed Consent Exclusion Criteria: * More than 2 previous chemotherapy lines * Single tumor lesion inside a previous irradiated filed * Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test) * Active infection requiring antibiotics * Symptomatic peripheral neuropathy \> grade 2 according to the NCI Common Toxicity Criteria. * Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia. * Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives * Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
References
Publications (17)
- BACKGROUNDSchoffski P, Casali PP, Taron M, et al. Impact of the DNA repair functionality on the outcome of sarcoma patients treated with trabectedin (ET-743). J Clin Oncol, 2006; 24 (18 Suppl):525s (Abstract#9522)
- RESULTBerton-Rigaud D, Devouassoux-Shisheboran M, Ledermann JA, Leitao MM, Powell MA, Poveda A, Beale P, Glasspool RM, Creutzberg CL, Harter P, Kim JW, Reed NS, Ray-Coquard I. Gynecologic Cancer InterGroup (GCIG) consensus review for uterine and ovarian carcinosarcoma. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S55-60. doi: 10.1097/IGC.0000000000000228. PMID 25341582
- RESULTMakker V, Abu-Rustum NR, Alektiar KM, Aghajanian CA, Zhou Q, Iasonos A, Hensley ML. A retrospective assessment of outcomes of chemotherapy-based versus radiation-only adjuvant treatment for completely resected stage I-IV uterine carcinosarcoma. Gynecol Oncol. 2008 Nov;111(2):249-54. doi: 10.1016/j.ygyno.2008.06.035. Epub 2008 Aug 27. PMID 18755503
- RESULTCicin I, Saip P, Eralp Y, Selam M, Topuz S, Ozluk Y, Aydin Y, Topuz E. Ovarian carcinosarcomas: clinicopathological prognostic factors and evaluation of chemotherapy regimens containing platinum. Gynecol Oncol. 2008 Jan;108(1):136-40. doi: 10.1016/j.ygyno.2007.09.003. Epub 2007 Oct 23. PMID 17936342
- RESULTJonson AL, Bliss RL, Truskinovsky A, Judson P, Argenta P, Carson L, Dusenbery K, Downs LS Jr. Clinical features and outcomes of uterine and ovarian carcinosarcoma. Gynecol Oncol. 2006 Mar;100(3):561-4. doi: 10.1016/j.ygyno.2005.09.017. Epub 2005 Nov 4. PMID 16271748
- RESULTReed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2.