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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00474994 |
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 | Intervention | Phase |
---|---|---|
Adult Malignant Fibrous Histiocytoma of Bone Desmoid Tumor Endometrial Cancer Ovarian Cancer Sarcoma Small Intestine Cancer |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas |
Estimated Enrollment: | 102 |
Study Start Date: | April 2007 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed connective tissue neoplasm, including any of the following neoplastic subtypes:
Measurable disease
Prior standard neoadjuvant or adjuvant systemic therapy required for patients with the following diagnoses:
PATIENT CHARACTERISTICS:
No other disease or illness within the past 6 months, including any of the following:
PRIOR CONCURRENT THERAPY:
No more than 3 prior cytotoxic chemotherapy regimens for metastatic disease
At least 3 weeks since prior radiotherapy (except for palliative radiotherapy to specific sites)
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
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 |
Principal Investigator: | Mary L. Keohan, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Robert Maki, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Mary Louise Keohan ) |
Study ID Numbers: | CDR0000544501, MSKCC-07054, PFIZER-MSKCC-07054 |
Study First Received: | May 16, 2007 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00474994 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Sarcoma, Endometrial Stromal Fibrosarcoma Neuroectodermal Tumors, Primitive Fibroma Histiocytoma, Benign Fibrous Fibromatosis Urogenital Neoplasms Ileal Diseases Kaposi Sarcoma Malignant Fibrous Histiocytoma Sarcoma, Synovial Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Fibromatosis, Aggressive |
Osteogenic Sarcoma Neuroepithelioma Ovarian Cancer Sarcoma, Alveolar Soft Part Aggression Rhabdomyosarcoma Endocrine Gland Neoplasms Dermatofibrosarcoma Protuberans Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Aggressive Fibromatosis Ewing's Sarcoma Hemangiopericytoma Neuroectodermal Tumors |
Histiocytoma, Malignant Fibrous Fibroma Antineoplastic Agents Gastrointestinal Diseases Histiocytoma, Benign Fibrous Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Ileal Diseases Duodenal Neoplasms Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplasms by Site |
Fibromatosis, Aggressive Ileal Neoplasms Sunitinib Jejunal Diseases Therapeutic Uses Uterine Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Duodenal Diseases Endocrine Gland Neoplasms Jejunal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Growth Substances |