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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00474994
First received: May 16, 2007
Last updated: December 15, 2015
Last verified: December 2015
May 16, 2007
December 15, 2015
April 2007
November 2010   (Final data collection date for primary outcome measure)
Overall Objective Response [ Time Frame: 2 years ]
as assessed by RECIST criteria
Response rate (complete response [CR] and partial response [PR]) as assessed by RECIST
Complete list of historical versions of study NCT00474994 on ClinicalTrials.gov Archive Site
Not Provided
  • Progression-free survival rate (CR, PR, and stable disease) as assessed at 16 and 24 weeks
  • Overall survival
  • 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)
  • Tumor maximum standardized uptake value as assessed by fludeoxyglucose F 18-PET scan at baseline and at 2 weeks and correlation with clinical response
Not Provided
Not Provided
 
Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Malignant Fibrous Histiocytoma of Bone
  • Desmoid Tumor
  • Endometrial Cancer
  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
Drug: sunitinib malate
  • Experimental: Group A
    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: Drug: sunitinib malate
  • Experimental: Group B
    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: Drug: sunitinib malate
  • Experimental: Group C
    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: Drug: sunitinib malate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
November 2010
November 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00474994
07-054
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07054
PFIZER-MSKCC-07054
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • Dana-Farber Cancer Institute
Principal Investigator: Mary L. Keohan, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert Maki, MD, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP