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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-07054 | |||
| PFIZER-MSKCC-07054 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Dana-Farber Cancer Institute | OTHER |
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
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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. |
|
| Group B | Experimental | 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. |
|
| Group C | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib malate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | as assessed by RECIST criteria | 2 years |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed connective tissue neoplasm, including any of the following neoplastic subtypes:
Metastatic, locally advanced, or locally recurrent disease
Measurable disease
No gastrointestinal stromal tumor sarcomas
Prior standard neoadjuvant or adjuvant systemic therapy required for patients with the following diagnoses:
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:
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
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)
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)
No other concurrent approved or investigational anticancer agents or treatment, including chemotherapy, biological response modifier therapy, hormonal therapy, or immunotherapy
No concurrent antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
No concurrent rifampin, theophylline, ketoconazole, or Hypericum perforatum (St. John's wort)
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| Name | Affiliation | Role |
|---|---|---|
| Mary L. Keohan, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Robert Maki, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19451429 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas | Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Memorial Sloan-Kettering Cancer Center |
| New York |
| New York |
| 10021 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas | Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Objective Response | as assessed by RECIST criteria | Posted | Number | participants | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas | Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas | 9 | 53 | 37 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death not associated with CTCAE term- Death NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not associated with CTCAE term-Disease progression NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTC-3.0 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pneumothorax | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
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| Ulcer, Duodenum | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
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| Gastrointestinal, other | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTC-3.0 | Systematic Assessment |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Mucositis (Clincal exam)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Keohan | Memorial Sloan Kettering Cancer Center | 646-888-4160 | KeohanM@mskcc.org |
| ID | Term |
|---|---|
| D051677 | Histiocytoma, Malignant Fibrous |
| D018222 | Desmoid Tumors |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D002813 | Chondrosarcoma |
| D012516 | Osteosarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D012514 | Sarcoma, Kaposi |
| D007890 | Leiomyosarcoma |
| D012208 | Rhabdomyosarcoma |
| D018223 | Dermatofibrosarcoma |
| D006394 | Hemangiosarcoma |
| D018203 | Sarcoma, Endometrial Stromal |
| D018234 | Sarcoma, Alveolar Soft Part |
| C563195 | Chondrosarcoma, Extraskeletal Myxoid |
| D005354 | Fibrosarcoma |
| C562740 | Hemangiopericytoma, Malignant |
| C535700 | Malignant mesenchymal tumor |
| D018319 | Neurofibrosarcoma |
| D013584 | Sarcoma, Synovial |
| D058405 | Desmoplastic Small Round Cell Tumor |
| D008080 | Liposarcoma |
| D001859 | Bone Neoplasms |
| C554498 | AIDS-related Kaposi sarcoma |
| ID | Term |
|---|---|
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005350 | Fibroma |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018213 | Neoplasms, Bone Tissue |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009383 | Neoplasms, Vascular Tissue |
| D009379 | Neoplasms, Muscle Tissue |
| D009217 | Myosarcoma |
| D018193 | Neoplasms, Complex and Mixed |
| D036821 | Endometrial Stromal Tumors |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D018205 | Neoplasms, Adipose Tissue |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Title | Measurements |
|---|---|
|