Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Not Recruiting

Trial ID: NCT00379145


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.

Official Title

A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor



* 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)


* 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
* 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


* 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 agents


drug: Trabectedin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maureen Sutton

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