Clinical trial · Interventional
Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas
NCT00379145CI-TRIAL-00030768completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trabectedin
- description
- Trabectedin IV over 24 hours every 3 weeks
- interventionNames
- Drug: trabectedin
Primary outcomes (2)
- measure
- Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
- timeFrame
- CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
- description
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed uterine leiomyosarcoma
* Histological confirmation of original primary tumor required
* Advanced, persistent, or recurrent disease
* Documented disease progression
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, and MRI OR ≥ 10 mm by spiral CT scan
* At least 1 target lesion
* Tumors within a previously irradiated field are considered nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy
* Ineligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
* GOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Platelet count ≥ 100,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin \> 9.0 g/dL
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin normal
* AST ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 1.5 times ULN
* CPK ≤ ULN
* No active infection requiring antibiotics (except for patients with uncomplicated UTI)
* No neuropathy (sensory or motor) \> grade 1
* No other invasive malignancy within the past 5 years except for nonmelanoma skin cancer
* No known active liver disease or hepatitis
* Must be willing/able to have a central venous catheter
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior surgery, radiotherapy, or other therapy
* No prior cancer treatment that would preclude study therapy
* No prior cytotoxic chemotherapy or biologic therapy for uterine sarcoma
* No prior chemotherapy for any abdominal or pelvic tumor within the past 5 years
* Prior adjuvant chemotherapy for localized breast cancer is allowed provided it was completed more than 3 years ago and there is no evidence of recurrent or metastatic disease
* No prior trabectedin
* No prior radiotherapy within the past 5 years to any portion of the abdominal cavity or pelvis other than for treatment of uterine sarcoma
* Prior radiotherapy for localized cancer of the breast, head and neck or skin is allowed, provided that it was completed more than 3 years ago and there is no evidence of recurrent or metastatic disease
* At least 1 week since prior hormonal therapy for the malignancy (continuation of hormone replacement therapy is permitted)
* No concurrent amifostine or other protective agentsReferences
Publications (2)
- BACKGROUNDTewari D, Saffari B, Cowan C, Wallick AC, Koontz MZ, Monk BJ. Activity of trabectedin (ET-743, Yondelis) in metastatic uterine leiomyosarcoma. Gynecol Oncol. 2006 Sep;102(3):421-4. doi: 10.1016/j.ygyno.2006.04.025. Epub 2006 Jun 23. PMID 16797679
- RESULTMonk BJ, Blessing JA, Street DG, Muller CY, Burke JJ, Hensley ML. A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study. Gynecol Oncol. 2012 Jan;124(1):48-52. doi: 10.1016/j.ygyno.2011.09.019. Epub 2011 Oct 13. PMID 21996263