trabectedin in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus

Conditions: Sarcoma

Summary: 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.

objectives: * determine the antitumor activity of trabectedin, as measured by frequency and duration of objective response, in patients with advanced, persistent, or recurrent uterine leiomyosarcoma. * determine the nature and degree of toxicity of this drug in these patients. outline: this is a nonrandomized, multicenter study. patients receive trabectedin iv continuously over 24 hours on day 1. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients who achieve a confirmed complete response may receive at least 2 additional courses. after completion of study treatment, patients are followed every 3 months. projected accrual: a total of 43 patients will be accrued for this study.

Eligibility criteria:
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 agents

Keywords: uterine leiomyosarcoma recurrent uterine sarcoma stage iii uterine sarcoma stage iv uterine sarcoma