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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00378911 |
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 recurrent or persistent leiomyosarcoma of the uterus.
Condition | Intervention | Phase |
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Sarcoma |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511, IND #74019) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus |
Estimated Enrollment: | 44 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed leiomyosarcoma of the uterus
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion to assess response
Received at least 1 but no more than 2 prior cytotoxic regimens
PATIENT CHARACTERISTICS:
No NYHA class III-IV congestive heart failure
No uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No concurrent proarrhythmic potential agent, including any of the following:
No concurrent therapeutic coumarin-derivative anticoagulants, such as warfarin
Study Chair: | Martee L. Hensley, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000495190, GOG-0231C |
Study First Received: | September 19, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00378911 History of Changes |
Health Authority: | United States: Food and Drug Administration |
uterine leiomyosarcoma recurrent uterine sarcoma |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sunitinib Leiomyosarcoma |
Uterine Sarcoma Sarcoma Angiogenesis Inhibitors Recurrence |
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Leiomyosarcoma Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms, Connective and Soft Tissue Neoplasms Sunitinib Therapeutic Uses Sarcoma Growth Inhibitors Angiogenesis Modulating Agents |