Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Completed · Phase 2

Conditions studied: Recurrent Uterine Sarcoma, Uterine Leiomyosarcoma

In brief

This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00378911

Run by

National Cancer Institute (NCI)

People needed

44

Starts

2006-10-01

Expected to finish

2010-01-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed leiomyosarcoma of the uterus
• Recurrent or persistent disease
• Refractory to curative therapy or established treatments
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Ascites and pleural effusions are not considered measurable disease
• Must have ≥ 1 target lesion to assess response
• Tumors in a previously irradiated field are considered non-target lesions unless there is documented progression or biopsy-confirmed persistence ≥ 90 days after completion of radiotherapy
• Received at least 1 but no more than 2 prior cytotoxic regimens
• Initial treatment may have included high-dose chemotherapy, consolidation, or extended therapy administered after surgery or nonsurgical assessment
• Cytotoxic regimens may have included any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• Not a candidate for a higher priority GOG protocol
• No known brain metastases
• GOG performance status 0-2 (for patients who have received 1 prior regimen) OR GOG 0-1 (for patients who have received 2 prior regimens)
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 1.5 times ULN
• QTc < 500 msec
• LVEF normal by echocardiogram
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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