Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Drug: trabectedin


Phase 2



   - 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

   - 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

   - 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

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maureen Sutton
Not Recruiting