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Trial record 53 of 58344 for:    Placebo

Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT00393796
Recruitment Status : Terminated (Low accrual)
First Posted : October 30, 2006
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bladder Cancer
Interventions Drug: SUTENT
Other: Placebo
Enrollment 54
Recruitment Details Participants were originally randomized to SUTENT or Placebo (Double Blind Period). 26 participants were randomized to SUTENT. Of the 28 participants randomized to Placebo, those that progressed were offered SUTENT if they were eligible.
Pre-assignment Details  
Arm/Group Title SUTENT Placebo
Hide Arm/Group Description Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
Period Title: Double Blind Period
Started 26 28
Completed 26 28
Not Completed 0 0
Period Title: Open Label Period - Placebo to SUTENT
Started 0 16
Completed 0 16
Not Completed 0 0
Arm/Group Title SUTENT Placebo Total
Hide Arm/Group Description Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. Total of all reporting groups
Overall Number of Baseline Participants 26 28 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants 28 participants 54 participants
69
(48 to 84)
69
(53 to 81)
69
(48 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Female
6
  23.1%
9
  32.1%
15
  27.8%
Male
20
  76.9%
19
  67.9%
39
  72.2%
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
PS=0 10 11 21
PS=1 15 17 32
PS=2 1 0 1
[1]
Measure Description: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is a measure of general well being and activities of daily life. Scores run from 0 to 5 where 0 denotes normal activity and 5 represents death.
Visceral Metastasis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
9 12 21
[1]
Measure Description: The number of participants presenting with visceral metastasis.
Bladder Primary Tumor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
20 18 38
[1]
Measure Description: The number of participants presenting with primary bladder tumors.
Mixed Histology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
2 4 6
[1]
Measure Description: The number of participants presenting with mixed histology.
Prior Chemotherapy Regimen   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Cisplatin and gemcitabine 10 14 24
MVAC 3 2 5
Non-cisplatin-containing chemotherapy 13 12 25
[1]
Measure Description: The number of participants that had the following prior chemotherapy regimens: Cisplatin and gemcitabine, MVAC (methotrexate, vinblastine, doxorubicin and cisplatin), Non-cisplatin-containing chemotherapy.
Response to Prior Chemotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
CR 3 1 4
PR 10 12 22
SD 13 15 28
[1]
Measure Description: The number of participants that experienced the following best overall response from prior chemotherapy: CR (Complete Response), PR (Partial Response), and SD (Stable Disease).
1.Primary Outcome
Title Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo
Hide Description

The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.

Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time Frame 6 Months Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SUTENT Placebo
Hide Arm/Group Description:
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
Overall Number of Participants Analyzed 26 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.7
(54 to 87)
64.3
(47 to 81)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SUTENT Placebo Only
Hide Arm/Group Description

Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.

26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT.

Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.

28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT.

All-Cause Mortality
SUTENT Placebo Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SUTENT Placebo Only
Affected / at Risk (%) Affected / at Risk (%)
Total   17/42 (40.48%)   6/28 (21.43%) 
Blood and lymphatic system disorders     
Hemoglobin  2/42 (4.76%)  1/28 (3.57%) 
Platelets  2/42 (4.76%)  1/28 (3.57%) 
Cardiac disorders     
Cardiac General - Other  1/42 (2.38%)  1/28 (3.57%) 
Gastrointestinal disorders     
Constipation  1/42 (2.38%)  0/28 (0.00%) 
Nausea  1/42 (2.38%)  1/28 (3.57%) 
Obstruction, GI  1/42 (2.38%)  0/28 (0.00%) 
Pancreatitis  0/42 (0.00%)  1/28 (3.57%) 
General disorders     
Death not associated with CTCAE term  5/42 (11.90%)  3/28 (10.71%) 
Fatigue (asthenia, lethargy, malaise)  2/42 (4.76%)  1/28 (3.57%) 
Pain  1/42 (2.38%)  2/28 (7.14%) 
Infections and infestations     
Infection with Grade 3 or 4 neutrophils  2/42 (4.76%)  1/28 (3.57%) 
Infection with unknown ANC  1/42 (2.38%)  1/28 (3.57%) 
Infection with normal ANC or Grade 1 or 2 neutrophils  0/42 (0.00%)  1/28 (3.57%) 
Metabolism and nutrition disorders     
Dehydration  1/42 (2.38%)  0/28 (0.00%) 
Potassium, serum-low (hypokalemia)  1/42 (2.38%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy)  1/42 (2.38%)  1/28 (3.57%) 
Nervous system disorders     
Syncope (fainting)  1/42 (2.38%)  1/28 (3.57%) 
Psychiatric disorders     
Psychosis (hallucinations/delusions)  1/42 (2.38%)  1/28 (3.57%) 
Renal and urinary disorders     
Renal failure  1/42 (2.38%)  1/28 (3.57%) 
Urinary retention (including neurogenic bladder)  1/42 (2.38%)  1/28 (3.57%) 
Obstruction, GU  0/42 (0.00%)  1/28 (3.57%) 
Vascular disorders     
Hemorrhage, GI  1/42 (2.38%)  1/28 (3.57%) 
Thrombosis/thrombus/embolism  1/42 (2.38%)  1/28 (3.57%) 
CNS cerebrovascular ischemia  0/42 (0.00%)  1/28 (3.57%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SUTENT Placebo Only
Affected / at Risk (%) Affected / at Risk (%)
Total   42/42 (100.00%)   28/28 (100.00%) 
Blood and lymphatic system disorders     
Blood/Bone Marrow - Other (Specify)  1/42 (2.38%)  1/28 (3.57%) 
Hemoglobin  18/42 (42.86%)  13/28 (46.43%) 
Hemoglobinuria  1/42 (2.38%)  0/28 (0.00%) 
Leukocytes (total WBC)  13/42 (30.95%)  6/28 (21.43%) 
Leukopenia  4/42 (9.52%)  2/28 (7.14%) 
Lymphopenia  6/42 (14.29%)  3/28 (10.71%) 
Neutrophils/granulocytes (ANC/AGC)  6/42 (14.29%)  7/28 (25.00%) 
Platelets  24/42 (57.14%)  10/28 (35.71%) 
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)  0/42 (0.00%)  1/28 (3.57%) 
Cardiac disorders     
Cardiac Arrhythmia - Other (Specify)  1/42 (2.38%)  1/28 (3.57%) 
Cardiac General - Other (Specify)  1/42 (2.38%)  1/28 (3.57%) 
Hypertension  14/42 (33.33%)  10/28 (35.71%) 
Hypotension  2/42 (4.76%)  1/28 (3.57%) 
Left ventricular systolic dysfunction  1/42 (2.38%)  2/28 (7.14%) 
Supraventricular and nodal arrhythmia  2/42 (4.76%)  0/28 (0.00%) 
Left ventricular diastolic dysfunction  0/42 (0.00%)  1/28 (3.57%) 
Ear and labyrinth disorders     
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program  1/42 (2.38%)  1/28 (3.57%) 
Hearing: patients without baseline audiogram and not enrolled in a monitoring program  2/42 (4.76%)  1/28 (3.57%) 
Tinnitus  1/42 (2.38%)  0/28 (0.00%) 
Endocrine disorders     
Endocrine - Other  1/42 (2.38%)  0/28 (0.00%) 
Thyroid function, high (hyperthyroidism, thyrotoxicosis)  1/42 (2.38%)  0/28 (0.00%) 
Thyroid function, low (hypothyroidism)  6/42 (14.29%)  5/28 (17.86%) 
Eye disorders     
Vision-blurred vision  1/42 (2.38%)  0/28 (0.00%) 
Watery eye (epiphora, tearing)  2/42 (4.76%)  0/28 (0.00%) 
Gastrointestinal disorders     
Colitis  1/42 (2.38%)  1/28 (3.57%) 
Constipation  15/42 (35.71%)  11/28 (39.29%) 
Diarrhea  24/42 (57.14%)  12/28 (42.86%) 
Distension/bloating, abdominal  5/42 (11.90%)  3/28 (10.71%) 
Dry mouth/salivary gland (xerostomia)  4/42 (9.52%)  1/28 (3.57%) 
Dysphagia (difficulty swallowing)  1/42 (2.38%)  0/28 (0.00%) 
Flatulence  4/42 (9.52%)  1/28 (3.57%) 
Gastritis (including bile reflux gastritis)  4/42 (9.52%)  1/28 (3.57%) 
Gastrointestinal - Other  1/42 (2.38%)  1/28 (3.57%) 
Heartburn/dyspepsia  3/42 (7.14%)  3/28 (10.71%) 
Hemorrhoids  3/42 (7.14%)  1/28 (3.57%) 
Incontinence, anal  1/42 (2.38%)  0/28 (0.00%) 
Mucositis/stomatitis (functional/symptomatic)  6/42 (14.29%)  1/28 (3.57%) 
Nausea  17/42 (40.48%)  11/28 (39.29%) 
Obstruction, GI  1/42 (2.38%)  1/28 (3.57%) 
Taste alteration (dysgeusia)  13/42 (30.95%)  6/28 (21.43%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  4/42 (9.52%)  1/28 (3.57%) 
Vomiting  11/42 (26.19%)  6/28 (21.43%) 
Obstruction, GU  0/42 (0.00%)  1/28 (3.57%) 
General disorders     
Constitutional Symptoms - Other  5/42 (11.90%)  4/28 (14.29%) 
Death not associated with CTCAE term  5/42 (11.90%)  3/28 (10.71%) 
Edema: head and neck  4/42 (9.52%)  2/28 (7.14%) 
Edema: limb  5/42 (11.90%)  6/28 (21.43%) 
Fatigue (asthenia, lethargy, malaise)  30/42 (71.43%)  23/28 (82.14%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <'1.0 x 10e9/L)  5/42 (11.90%)  3/28 (10.71%) 
Injection site reaction/extravasation changes  1/42 (2.38%)  1/28 (3.57%) 
Pain  42/42 (100.00%)  28/28 (100.00%) 
Pain - Other  9/42 (21.43%)  8/28 (28.57%) 
Rigors/chills  6/42 (14.29%)  4/28 (14.29%) 
Sweating (diaphoresis)  2/42 (4.76%)  1/28 (3.57%) 
Weight loss  5/42 (11.90%)  2/28 (7.14%) 
Hepatobiliary disorders     
Liver dysfunction/failure (clinical)  1/42 (2.38%)  0/28 (0.00%) 
Infections and infestations     
Infection with Grade 3 or 4 neutrophils  4/42 (9.52%)  4/28 (14.29%) 
Infection with normal ANC or Grade 1 or 2 neutrophils  5/42 (11.90%)  3/28 (10.71%) 
Infection with unknown ANC  3/42 (7.14%)  3/28 (10.71%) 
Pancreatitis  0/42 (0.00%)  1/28 (3.57%) 
Injury, poisoning and procedural complications     
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1/42 (2.38%)  1/28 (3.57%) 
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  6/42 (14.29%)  4/28 (14.29%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  11/42 (26.19%)  5/28 (17.86%) 
Alkaline phosphatase  4/42 (9.52%)  5/28 (17.86%) 
CD4 count  3/42 (7.14%)  1/28 (3.57%) 
Creatinine  15/42 (35.71%)  11/28 (39.29%) 
Hyperbilirubinemia  1/42 (2.38%)  2/28 (7.14%) 
Mucositis/stomatitis (clinical exam)  5/42 (11.90%)  0/28 (0.00%) 
PTT (Partial Thromboplastin Time)  2/42 (4.76%)  0/28 (0.00%) 
INR (International Normalized Ratio of prothrombin time)  0/42 (0.00%)  1/28 (3.57%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  5/42 (11.90%)  3/28 (10.71%) 
Anorexia  20/42 (47.62%)  12/28 (42.86%) 
Calcium, serum-low (hypocalcemia)  6/42 (14.29%)  4/28 (14.29%) 
Dehydration  7/42 (16.67%)  3/28 (10.71%) 
Glucose, serum-high (hyperglycemia)  10/42 (23.81%)  11/28 (39.29%) 
Glucose, serum-low (hypoglycemia)  1/42 (2.38%)  1/28 (3.57%) 
Hyperglycemia  3/42 (7.14%)  3/28 (10.71%) 
Hyperkalemia  1/42 (2.38%)  0/28 (0.00%) 
Hypoglycemia  2/42 (4.76%)  1/28 (3.57%) 
Lipase  1/42 (2.38%)  0/28 (0.00%) 
Magnesium, serum-high (hypermagnesemia)  2/42 (4.76%)  1/28 (3.57%) 
Magnesium, serum-low (hypomagnesemia)  4/42 (9.52%)  1/28 (3.57%) 
Metabolic/Laboratory - Other  3/42 (7.14%)  2/28 (7.14%) 
Phosphate, serum-low (hypophosphatemia)  1/42 (2.38%)  0/28 (0.00%) 
Potassium, serum-high (hyperkalemia)  4/42 (9.52%)  2/28 (7.14%) 
Potassium, serum-low (hypokalemia)  2/42 (4.76%)  0/28 (0.00%) 
Sodium, serum-low (hyponatremia)  7/42 (16.67%)  3/28 (10.71%) 
Uric acid, serum-high (hyperuricemia)  1/42 (2.38%)  0/28 (0.00%) 
Calcium, serum-high (hypercalcemia)  0/42 (0.00%)  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders     
Arthritis (non-septic)  3/42 (7.14%)  1/28 (3.57%) 
Joint-function  1/42 (2.38%)  1/28 (3.57%) 
Muscle weakness, generalized or specific area (not due to neuropathy)  8/42 (19.05%)  5/28 (17.86%) 
Nervous system disorders     
Ataxia (incoordination)  1/42 (2.38%)  1/28 (3.57%) 
Confusion  2/42 (4.76%)  2/28 (7.14%) 
Dizziness  7/42 (16.67%)  11/28 (39.29%) 
Memory impairment  3/42 (7.14%)  3/28 (10.71%) 
Neurology - Other  2/42 (4.76%)  2/28 (7.14%) 
Neuropathy: cranial  1/42 (2.38%)  0/28 (0.00%) 
Neuropathy: motor  4/42 (9.52%)  2/28 (7.14%) 
Neuropathy: sensory  13/42 (30.95%)  6/28 (21.43%) 
Syncope (fainting)  3/42 (7.14%)  2/28 (7.14%) 
Tremor  2/42 (4.76%)  1/28 (3.57%) 
Psychiatric disorders     
Insomnia  3/42 (7.14%)  2/28 (7.14%) 
Mood alteration  2/42 (4.76%)  1/28 (3.57%) 
Psychosis (hallucinations/delusions)  1/42 (2.38%)  1/28 (3.57%) 
Renal and urinary disorders     
Cystitis  5/42 (11.90%)  3/28 (10.71%) 
Incontinence, urinary  2/42 (4.76%)  2/28 (7.14%) 
Proteinuria  2/42 (4.76%)  1/28 (3.57%) 
Renal failure  2/42 (4.76%)  1/28 (3.57%) 
Renal/Genitourinary - Other  3/42 (7.14%)  2/28 (7.14%) 
Urinary frequency/urgency  4/42 (9.52%)  8/28 (28.57%) 
Urinary retention (including neurogenic bladder)  1/42 (2.38%)  1/28 (3.57%) 
Reproductive system and breast disorders     
Erectile dysfunction  1/42 (2.38%)  1/28 (3.57%) 
Vaginal dryness  0/42 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  2/42 (4.76%)  0/28 (0.00%) 
Bronchospasm, wheezing  1/42 (2.38%)  1/28 (3.57%) 
Cough  12/42 (28.57%)  9/28 (32.14%) 
Dyspnea (shortness of breath)  10/42 (23.81%)  6/28 (21.43%) 
Nasal cavity/paranasal sinus reactions  1/42 (2.38%)  0/28 (0.00%) 
Obstruction/stenosis of airway  1/42 (2.38%)  0/28 (0.00%) 
Pulmonary/Upper Respiratory - Other (Specify)  2/42 (4.76%)  2/28 (7.14%) 
Hypoxia  0/42 (0.00%)  1/28 (3.57%) 
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other (Specify)  9/42 (21.43%)  2/28 (7.14%) 
Dry skin  9/42 (21.43%)  2/28 (7.14%) 
Hair loss/alopecia (scalp or body)  6/42 (14.29%)  5/28 (17.86%) 
Pruritus/itching  4/42 (9.52%)  2/28 (7.14%) 
Rash/desquamation  10/42 (23.81%)  6/28 (21.43%) 
Rash: acne/acneiform  1/42 (2.38%)  0/28 (0.00%) 
Rash: hand-foot skin reaction  7/42 (16.67%)  3/28 (10.71%) 
Ulceration  3/42 (7.14%)  1/28 (3.57%) 
Urticaria (hives, welts, wheals)  1/42 (2.38%)  1/28 (3.57%) 
Dermal change lymphedema, phlebolymphedema  0/42 (0.00%)  1/28 (3.57%) 
Hyperpigmentation  0/42 (0.00%)  1/28 (3.57%) 
Vascular disorders     
Hematoma  1/42 (2.38%)  0/28 (0.00%) 
Hemorrhage, GI  3/42 (7.14%)  2/28 (7.14%) 
Hemorrhage, GU  9/42 (21.43%)  5/28 (17.86%) 
Hemorrhage, pulmonary/upper respiratory  5/42 (11.90%)  1/28 (3.57%) 
Hemorrhage/Bleeding - Other (Specify)  3/42 (7.14%)  2/28 (7.14%) 
Hot flashes/flushes  1/42 (2.38%)  0/28 (0.00%) 
Lymphatics - Other  2/42 (4.76%)  0/28 (0.00%) 
Thrombosis/thrombus/embolism  1/42 (2.38%)  2/28 (7.14%) 
Vitreous hemorrhage  1/42 (2.38%)  0/28 (0.00%) 
CNS cerebrovascular ischemia  0/42 (0.00%)  1/28 (3.57%) 
This multicenter study was limited by premature closure and a small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Maha Hussain, M.D.
Organization: University of Michigan Comprehensive Cancer Center
Phone: 1-800-865-1125
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00393796     History of Changes
Other Study ID Numbers: UMCC 2005.145
First Submitted: October 27, 2006
First Posted: October 30, 2006
Results First Submitted: June 19, 2014
Results First Posted: November 13, 2014
Last Update Posted: November 13, 2014