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Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
This study has been completed.
First Received: May 16, 2007   Last Updated: January 21, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00474994
  Purpose

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.


Condition Intervention Phase
Adult Malignant Fibrous Histiocytoma of Bone
Desmoid Tumor
Endometrial Cancer
Ovarian Cancer
Sarcoma
Small Intestine Cancer
Drug: sunitinib malate
Phase II

MedlinePlus related topics: Cancer Intestinal Cancer Kaposi's Sarcoma Ovarian Cancer Soft Tissue Sarcoma
Drug Information available for: Sunitinib malate Sunitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete response [CR] and partial response [PR]) as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival rate (CR, PR, and stable disease) as assessed at 16 and 24 weeks [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Correlation of clinical response with changes in soluble angiogenesis mediator levels as assessed at baseline and at 2 weeks (for patients enrolled at the Memorial Sloan-Kettering Cancer Center) [ Designated as safety issue: No ]
  • Tumor maximum standardized uptake value (SUV) as assessed by fludeoxyglucose F 18-PET scan at baseline and at 2 weeks [ Designated as safety issue: No ]
  • Correlation of tumor maximum SUV with clinical response [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: April 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474994

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Mary L. Keohan, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Robert Maki, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Mary Louise Keohan )
Study ID Numbers: CDR0000544501, MSKCC-07054, PFIZER-MSKCC-07054
Study First Received: May 16, 2007
Last Updated: January 21, 2009
ClinicalTrials.gov Identifier: NCT00474994     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chondrosarcoma
recurrent osteosarcoma
localized adult malignant fibrous histiocytoma of bone
metastatic adult malignant fibrous histiocytoma of bone
recurrent adult malignant fibrous histiocytoma of bone
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Kaposi sarcoma
recurrent uterine sarcoma
adult leiomyosarcoma
adult malignant fibrous histiocytoma
adult rhabdomyosarcoma
dermatofibrosarcoma protuberans
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
ovarian sarcoma
uterine leiomyosarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
desmoid tumor
adult angiosarcoma
recurrent adult soft tissue sarcoma
uterine carcinosarcoma
endometrial stromal sarcoma
fibrosarcomatous osteosarcoma
chondrosarcomatous osteosarcoma
adult alveolar soft-part sarcoma
adult epithelioid sarcoma
adult extraskeletal chondrosarcoma
adult extraskeletal osteosarcoma
adult fibrosarcoma

Study placed in the following topic categories:
Sarcoma, Endometrial Stromal
Fibrosarcoma
Neuroectodermal Tumors, Primitive
Fibroma
Histiocytoma, Benign Fibrous
Fibromatosis
Urogenital Neoplasms
Ileal Diseases
Kaposi Sarcoma
Malignant Fibrous Histiocytoma
Sarcoma, Synovial
Duodenal Neoplasms
Neoplasms, Connective and Soft Tissue
Endometrial Neoplasms
Fibromatosis, Aggressive
Osteogenic Sarcoma
Neuroepithelioma
Ovarian Cancer
Sarcoma, Alveolar Soft Part
Aggression
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Dermatofibrosarcoma Protuberans
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Aggressive Fibromatosis
Ewing's Sarcoma
Hemangiopericytoma
Neuroectodermal Tumors

Additional relevant MeSH terms:
Histiocytoma, Malignant Fibrous
Fibroma
Antineoplastic Agents
Gastrointestinal Diseases
Histiocytoma, Benign Fibrous
Gonadal Disorders
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Ileal Diseases
Duodenal Neoplasms
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Endometrial Neoplasms
Neoplasms by Site
Fibromatosis, Aggressive
Ileal Neoplasms
Sunitinib
Jejunal Diseases
Therapeutic Uses
Uterine Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Growth Substances

ClinicalTrials.gov processed this record on May 07, 2009