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A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas

Phase 2
18 Years
Not Enrolling
Adult Malignant Fibrous Histiocytoma of Bone, Desmoid Tumor, Endometrial Cancer, Ovarian Cancer, Sarcoma, Small Intestine Cancer

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Trial Information

A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas



- 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.


- 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.

Inclusion Criteria


- 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

- 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


- 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

- 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


- 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

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response [CR] and partial response [PR]) as assessed by RECIST criteria

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mary L. Keohan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

November 2010

Related Keywords:

  • Adult Malignant Fibrous Histiocytoma of Bone
  • Desmoid Tumor
  • Endometrial Cancer
  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
  • 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
  • adult malignant hemangiopericytoma
  • adult malignant mesenchymoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • adult desmoplastic small round cell tumor
  • adult liposarcoma
  • anaplastic osteosarcoma
  • mixed osteosarcoma
  • small intestine leiomyosarcoma
  • osteoblastic osteosarcoma
  • telangiectatic osteosarcoma
  • classic Kaposi sarcoma
  • immunosuppressive treatment related Kaposi sarcoma
  • AIDS-related Kaposi sarcoma
  • Histiocytoma
  • Endometrial Neoplasms
  • Fibrosis
  • Ovarian Neoplasms
  • Fibromatosis, Aggressive
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Histiocytoma, Benign Fibrous
  • Adenoma
  • Histiocytoma, Malignant Fibrous
  • Intestinal Neoplasms
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115