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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 44

Inclusion Criteria

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
Patients with a pre-existing thyroid abnormality unable to maintain normal thyroid function with medication are not eligible
No significant EKG abnormalities (i.e., no history of serious ventricular arrhythmia OR EKG with ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
No sensory or motor neuropathy > grade 1
No NYHA class III-IV congestive heart failure
- NYHA class II cardiac dysfunction allowed
- History of NYHA class II heart failure that is asymptomatic on treatment allowed
No active infection requiring antibiotics
No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
No gastrointestinal tract disease resulting in an inability to take oral medication
No requirement for IV alimentation
No active peptic ulcer disease
No other condition that would impair ability to swallow and retain study drug
No serious or nonhealing wound, ulcer, or bone fracture
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
No cerebrovascular accident or transient ischemic attack within the past year
No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or symptomatic congestive heart failure within the past year
No pulmonary embolism within the past year
No uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infections
- Psychiatric illness or social situations that would preclude study compliance
Recovered from prior surgery, chemotherapy, or radiotherapy
Prior anthracycline exposure and central thoracic radiation that included the heart allowed provided patient has New York Heart Association (NYHA) class II cardiac function
At least 1 week since prior hormonal therapy
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) or radiotherapy
At least 4 weeks since prior major surgery
At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and no recurrent or metastatic disease
At least 3 years since prior adjuvant chemotherapy for localized cancer of the breast and no recurrent or metastatic disease
No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma
No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma
No prior noncytotoxic chemotherapy for recurrent or persistent disease
No prior surgical procedures affecting absorption
No coronary or peripheral artery bypass graft or stenting within the past year
No other prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or vascular endothelial growth factor [VEGF] Trap)
No other prior cancer treatment that would preclude study treatment
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
- Azole fungals (e.g., ketoconazole or itraconazole)
- Clarithromycin
- Erythromycin
- Diltiazem
- Verapamil
- HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
- Delavirdine
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
- Rifampin
- Rifabutin
- Carbamazepine
- Phenobarbital
- Phenytoin
- Hypericum perforatum (St. John's wort)
- Efavirenz
- Tipranavir
No concurrent proarrhythmic potential agent, including any of the following:
- Terfenadine
- Quinidine
- Procainamide
- Disopyramide
- Sotalol
- Probucol
- Bepridil
- Haloperidol
- Risperidone
- Indapamide
- Flecainide
No concurrent therapeutic coumarin-derivative anticoagulants, such as warfarin
- Doses ≤ 2 mg daily allowed for prophylaxis of thrombosis
- Low molecular weight heparin allowed provided PT INR ≤ 1.5
No concurrent amifostine or other protective agents
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer agents or therapies

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (sunitinib malate)	sunitinib malate	Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	From study entry until disease progression, death or date of last contact., assessed up to 6 months
Frequency and severity of adverse events as assessed by CTCAE v 3.0	Up to 5 years	The frequency and severity of all toxicities will be tabulated.
Objective tumor response according to GOG RECIST criteria	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Duration of progression-free survival	Up to 5 years	Characterized graphically and using descriptive statistics such as median survival.
Duration of overall survival	From entry into the study to death or the date of last contact, assessed up to 5 years	Characterized graphically and using descriptive statistics such as median survival.

Trial Locations

Locations (1): Gynecologic Oncology Group
🇺🇸
Philadelphia, Pennsylvania, United States

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

Recruitment & Eligibility

Study & Design

Trial Locations

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