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Microtubule Inhibitor
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
Phase 2
Waitlist Available
Led By Robert Dreicer
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
No Placebo-Only Group
Summary
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Eligible Conditions
- Urethral Cancer
- Bladder Cancer
- Transitional Cell Cancer
- Urothelial Carcinoma
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
Side effects data
From 2010 Phase 2 trial • 51 Patients • NCT0002515586%
Anemia
80%
Fatigue
73%
Leukopenia
65%
Neutropenia
59%
Neuropathy Sensor
45%
Nausea
43%
Diarrhea Without Colostomy
41%
Alopecia
33%
Constipation
29%
Abdominal Pain
27%
Anorexia
24%
Vomitting
24%
Dyspnea
22%
Hypomagnesmia
20%
Infection Without Neutropenia
20%
Thrombocytopenia
20%
Hyperglycemia
16%
Sgot(Ast)
14%
Arthralgia
14%
Taste Disturbance
14%
Myalgia
14%
Alkaline Phosphatase
14%
Hyponatremia
12%
Dehydration
12%
Headache
12%
Rash Desquamation
12%
Nail Changes
10%
Dyspepsia/Heartburn
10%
Hypokalemia
10%
Insomnia
10%
Mood Alteration Anxiety/Agitation
10%
Weight Loss
10%
Mood Alteration Depression
10%
Pain Other
8%
Transfusion Prbc's
8%
Edema
8%
Hypertension
8%
Gi Other
8%
Hypoalbuminemia
8%
Sgot(Alt)
6%
Cough
6%
Pulmonary Other
6%
Confusion
6%
Flatulence
6%
Dizziness
6%
Dry Skin
6%
Stomatitis/Pharyngitis
6%
Allergic Reaction
6%
Lymphopenia
6%
Fever(No Neutropenia)
6%
Lymphatics
6%
Hypophosphatemia
6%
Metabolic Other
6%
Hypocalcemia
6%
Creatinine
6%
Voice Changes/Stridor/Larynx
4%
Chest Pain
4%
Pleural Effusion
4%
Pain Tumor
4%
Hypercalcemia
4%
Urinary Frequency/Urgency
4%
Prothrombin Time
4%
Hot Flashes/Flushes
4%
Thrombosis Embolism
4%
Hematuria No Vaginal Bleeding
4%
Ggt(Gamma-Glutamyltranspeptidase)
4%
Neuropathy Motor
4%
Partial Thromboplastin Time
4%
Pelvic Pain
2%
Bone Pain
2%
Neuropathic Pain
2%
Dysphagia Esophagitis Odynophagia
2%
Colitis
2%
Bilirubin
2%
Pain Rectal/Perirectal
2%
Extrapyramidal
2%
Hypoxia
2%
Pneumonitis/Pulmonary Infiltrates
2%
Gastritis
2%
Mouth Dryness
2%
Memory Loss
2%
Sense Of Smell
2%
Mucositis Rt
2%
Rigors Chills
2%
Ascites Non-Malignant
2%
GI Other
2%
Incontinence
2%
Proteinuria
2%
Allergic Rhinitis
2%
Inner Ear/Hearing
2%
Hypotension
2%
Sinus Tachycardia
2%
Weight Gain(No Vod)
2%
Constitutional Symptoms Other
2%
Skin Other
2%
Flushing
2%
Bruising
2%
Rectal Bleeding/Hematochezia
2%
Hepatic Other
2%
Febrile With Neutropenia
2%
Lymphatics Other
2%
Hypermagnesemia
2%
Hyperkalemia
2%
Neuropathy Cranial
2%
Vision Blurred
2%
Dysuria
2%
Renal/Gu Other
2%
Syndromes Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ixabepilone)
Awards & Highlights
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: Treatment (ixabepilone)Experimental Treatment1 Intervention
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patupilone
Not yet FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,535 Total Patients Enrolled
20 Trials studying Urethral Cancer
2,081 Patients Enrolled for Urethral Cancer
Robert DreicerPrincipal InvestigatorEastern Cooperative Oncology Group
1 Previous Clinical Trials
27 Total Patients Enrolled