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

Inclusion 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