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NCT00474994 · REGISTRY CONDITION SEARCH

Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

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
2016-01-20

RATIONALE: 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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.

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

Overall Objective Response

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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 or cytologically confirmed connective tissue neoplasm, including any of the following neoplastic subtypes: * Vascular connective tissue neoplasms * Leiomyosarcoma * Dermatofibrosarcoma protuberans * Chordoma * Desmoid tumors * High-grade undifferentiated pleomorphic sarcoma (e.g., malignant fibrous histiocytoma \[including myxofibrosarcoma\]) * Carcinosarcomas (e.g., malignant mixed Müllerian tumors) * Giant hemangiomata * Kaposi sarcoma * Metastatic, locally advanced, or locally recurrent disease * Measurable disease * Tumor lesions in a previously irradiated area may be considered measurable provided there is evidence of growth that cannot be attributed to necrosis or bleeding * No gastrointestinal stromal tumor sarcomas * Prior standard neoadjuvant or adjuvant systemic therapy required for patients with the following diagnoses: * Rhabdomyosarcoma * Osteosarcoma * Ewing sarcoma * No untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as documented on screening CT scan or MRI PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * PT and INR ≤ 1.5 * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL * Calcium ≤ 12 mg/dL * Blood glucose \< 150 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study therapy * Other malignancies allowed provided sarcoma is the primary disease requiring systemic therapy * Able to swallow oral medications * No other disease or illness within the past 6 months, including any of the following: * Myocardial infarction * Severe or unstable angina * Coronary or peripheral artery bypass graft * Symptomatic congestive heart failure * Cerebrovascular accident or transient ischemic attack * Pulmonary embolism * No evidence of a bleeding diathesis * No ongoing cardiac dysrhythmias \> grade 2 * No uncontrolled hypertension, defined as blood pressure \> 150/100 mm Hg despite optimal medical therapy * Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan * No psychiatric illness or social situation that would preclude study compliance * No pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication * No prolonged QTc interval (i.e., QTc \> 450 msec for males or QTc \> 470 msec for females) on baseline EKG * No hemorrhage ≥ grade 3 in the past 4 weeks PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * No prior sunitinib malate * No more than 3 prior cytotoxic chemotherapy regimens for metastatic disease * Adjuvant chemotherapy for sarcoma completed \> 1 year prior to study entry is not considered a line of prior treatment * At least 2 weeks since prior cytotoxic chemotherapy * At least 6 weeks since prior carmustine or mitomycin C * At least 1 week since prior biological therapy or small molecule kinase inhibitors * At least 3 weeks since prior radiotherapy (except for palliative radiotherapy to specific sites) * Prior palliative radiotherapy allowed provided it is considered medically necessary and there are other target lesions to assess * More than 4 weeks since prior major surgery * Concurrent major surgery allowed provided study drug is stopped 2 weeks before surgery and resumed 2 weeks after surgery * Concurrent palliative radiotherapy (e.g., focal radiotherapy to a bony metastasis for relieving bone pain) allowed * No other concurrent investigational drugs * No concurrent participation in another clinical trial * No concurrent therapeutic anticoagulation (e.g., warfarin) * Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices allowed provided requirements for PT and INR are met * No other concurrent approved or investigational anticancer agents or treatment, including chemotherapy, biological response modifier therapy, hormonal therapy, or immunotherapy * Concurrent hormone replacement therapy for adrenal insufficiency allowed * No concurrent antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) * No concurrent rifampin, theophylline, ketoconazole, or Hypericum perforatum (St. John's wort)
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Vascular connective tissue neoplasms, leiomyosarcoma, dermatofibrosarcoma protuberans (DFSP), desmoid tumors. Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles.
    intervention Names
    1. Drug: sunitinib malate
    label
    Group A
    type
    EXPERIMENTAL
  2. description
    High grade undifferentiated pleomorphic sarcoma (includes the older designation malignant fibrous histiocytoma \[MFH\]) and other non-GIST connective tissue tumors; may include carcinosarcomas.Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles.
    intervention Names
    1. Drug: sunitinib malate
    label
    Group B
    type
    EXPERIMENTAL
  3. description
    Chordomas. Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles.
    intervention Names
    1. Drug: sunitinib malate
    label
    Group C
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Group A
    2. Group B
    3. Group C
    name
    sunitinib malate
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
53
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    as assessed by RECIST criteria
    measure
    Overall Objective Response
    time Frame
    2 years
Full study description
brief Summary
RATIONALE: 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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.
detailed Description
OBJECTIVES: Primary * Determine the response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent non-gastrointestinal stromal tumor sarcomas treated with sunitinib malate. Secondary * Determine the 16- and 24-week progression-free survival rate (complete response, partial response, and stable disease) in patients treated with this drug. * Determine the overall survival in patients treated with this drug. * Correlate clinical response with changes in soluble angiogenesis mediator levels in patients treated with this drug. * Determine the tumor maximum standardized uptake values by fludeoxyglucose F 18-PET scan in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified by neoplastic subtype (vascular connective tissue neoplasms, leiomyosarcoma, dermatofibrosarcoma protuberans, chordoma, or desmoid tumors vs high-grade undifferentiated pleomorphic sarcoma \[i.e., malignant fibrous histiocytoma (including myxofibrosarcoma)\], or other nongastrointestinal connective tissue tumors \[including carcinosarcomas\]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.
Source references
references
  1. citation
    George S, Merriam P, Maki RG, Van den Abbeele AD, Yap JT, Akhurst T, Harmon DC, Bhuchar G, O'Mara MM, D'Adamo DR, Morgan J, Schwartz GK, Wagner AJ, Butrynski JE, Demetri GD, Keohan ML. Multicenter phase II trial of sunitinib in the treatment of nongastrointestinal stromal tumor sarcomas. J Clin Oncol. 2009 Jul 1;27(19):3154-60. doi: 10.1200/JCO.2008.20.9890. Epub 2009 May 18.
    pmid
    19451429
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice