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Kinase Inhibitor
Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Phase 2
Waitlist Available
Led By Gini Fleming
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
Sorafenib 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. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.
Eligible Conditions
- Uterine Sarcoma
- Uterine Carcinosarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Overall Response Rate
Secondary study objectives
Duration of Response
Overall Survival
Progression Free Survival
Side effects data
From 2014 Phase 2 trial • 20 Patients • NCT0150241020%
Pain
10%
Lipase increased
10%
Respiratory, thoracic and mediastinal disorders - Other
10%
Hypoalbuminemia
10%
Anorexia
10%
Pericardial effusion
10%
Atelectasis
10%
Blood bilirubin increased
10%
Neutrophil count decreased
10%
Musculoskeletal and connective tissue disorder - Other
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
10%
Pleural effusion
10%
Rash maculo-papular
10%
Alkaline phosphatase increased
10%
Hypocalcemia
10%
Hypophosphatemia
10%
Back pain
10%
Diarrhea
10%
Neck pain
10%
Lung infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 Relapsed/Refractory Rhabdomyosarcoma
Group 2 Relapsed/Refractory Wilms Tumor
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,524 Total Patients Enrolled
3 Trials studying Uterine Sarcoma
55 Patients Enrolled for Uterine Sarcoma
Gini FlemingPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
3 Previous Clinical Trials
3,174 Total Patients Enrolled