|Phase II||Treatment||Completed||18 and over||NCI, Other||CDR0000502192|
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.
Further Study Information
- 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.
- 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 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
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|Bradley J. Monk||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00379145
Information obtained from ClinicalTrials.gov on November 20, 2012
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