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

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ClinicalTrials.gov Identifier: NCT00474994
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adult Malignant Fibrous Histiocytoma of Bone Desmoid Tumor Endometrial Cancer Ovarian Cancer Sarcoma Small Intestine Cancer Drug: sunitinib malate Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Study Start Date : April 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 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.
 Drug: sunitinib malate


Outcome Measures
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Primary Outcome Measures :
  1. Overall Objective Response [ Time Frame: 2 years ]
    as assessed by RECIST criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
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
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Publications of Results:

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00474994     History of Changes
Other Study ID Numbers: 07-054
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07054
PFIZER-MSKCC-07054
First Posted: May 17, 2007    Key Record Dates
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
localized adult malignant fibrous histiocytoma of bone
metastatic adult malignant fibrous histiocytoma of bone
recurrent adult malignant fibrous histiocytoma of bone
adult malignant fibrous histiocytoma
chondrosarcoma
recurrent osteosarcoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Kaposi sarcoma
recurrent uterine sarcoma
adult leiomyosarcoma
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

Additional relevant MeSH terms:
Sarcoma
Endometrial Neoplasms
Intestinal Neoplasms
Fibromatosis, Aggressive
Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
 Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs