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Status:

COMPLETED

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

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

Brief 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 phas...

Detailed Description

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....

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT00379145

    Start Date

    June 1 2007

    Last Update

    December 12 2017

    Active Locations (32)

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    Page 1 of 8 (32 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, United States, 06102-5037

    3

    George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, United States, 06050

    4

    Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, United States, 20010