Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Condition: Sarcoma
MeSH terms: Sarcoma; Leiomyosarcoma
Intervention: trabectedin
Intervention MeSH terms: Trabectedin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: uterine leiomyosarcoma; recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine 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.
    

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