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

NCT00474994 | Completed Phase 2 Results

• 4 other identifiers: 07-054P30CA008748MSKCC-07054PFIZER-MSKCC-07054
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Adult Malignant Fibrous Histiocytoma of Bone; Desmoid Tumor; Endometrial Cancer; Ovarian Cancer; Sarcoma; Small Intestine Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response

  as assessed by RECIST criteria

  2 years

Study Arms (3)

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.

Drug: sunitinib malate

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.

Drug: sunitinib malate

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.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 19451429 RESULT

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous; Desmoid Tumors; Endometrial Neoplasms; Ovarian Neoplasms; Sarcoma; Chondrosarcoma; Osteosarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Sarcoma, Kaposi; Leiomyosarcoma; Rhabdomyosarcoma; Dermatofibrosarcoma; Hemangiosarcoma; Sarcoma, Endometrial Stromal; Sarcoma, Alveolar Soft Part; Chondrosarcoma, Extraskeletal Myxoid; Fibrosarcoma; Hemangiopericytoma, Malignant; Malignant mesenchymal tumor; Neurofibrosarcoma; Sarcoma, Synovial; Desmoplastic Small Round Cell Tumor; Liposarcoma; Bone Neoplasms; AIDS-related Kaposi sarcoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Fibroma; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Bone Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors; Neurofibroma; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neoplasms, Adipose Tissue; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Mary Keohan
• Organization: Memorial Sloan Kettering Cancer Center

KeohanM@mskcc.org

646-888-4160

Study Officials

• Mary L. Keohan, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert Maki, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 20, 2016
• Results First Posted: January 20, 2016

Record last verified: 2015-12

Locations

US (2)