Clinical trial NCT00378911 (phase 2, status: completed)
Conditions: recurrent uterine sarcoma, uterine leiomyosarcoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        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