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

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