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NCT00379145 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-12-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

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outcome · POSTED

Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Trabectedin IV over 24 hours every 3 weeks
    intervention Names
    1. Drug: trabectedin
    label
    Trabectedin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Trabectedin
    name
    trabectedin
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
    measure
    Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
    time Frame
    CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
  2. measure
    Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
    time Frame
    Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Full study description
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 phase II trial is studying how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
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. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a nonrandomized, multicenter study. Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Source references
references
  1. citation
    Tewari D, Saffari B, Cowan C, Wallick AC, Koontz MZ, Monk BJ. Activity of trabectedin (ET-743, Yondelis) in metastatic uterine leiomyosarcoma. Gynecol Oncol. 2006 Sep;102(3):421-4. doi: 10.1016/j.ygyno.2006.04.025. Epub 2006 Jun 23.
    pmid
    16797679
    type
    BACKGROUND
  2. citation
    Monk BJ, Blessing JA, Street DG, Muller CY, Burke JJ, Hensley ML. A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study. Gynecol Oncol. 2012 Jan;124(1):48-52. doi: 10.1016/j.ygyno.2011.09.019. Epub 2011 Oct 13.
    pmid
    21996263
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
        NCT00379145
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
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      source file sha256
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice