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Trial record 24 of 32 for:    "Urethra Cancer" | "Antimetabolites, Antineoplastic"

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT01611662
Recruitment Status : Terminated (Extreme Toxicity)
First Posted : June 5, 2012
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Distal Urethral Cancer
Proximal Urethral Cancer
Squamous Cell Carcinoma of the Bladder
Stage II Bladder Cancer
Stage III Bladder Cancer
Urethral Cancer Associated With Invasive Bladder Cancer
Interventions Drug: gemcitabine hydrochloride
Drug: cisplatin
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Hide Arm/Group Description

Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.

gemcitabine hydrochloride: Given IV

cisplatin: Given IV

therapeutic conventional surgery: Undergo radical cystectomy

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 32
Completed 31
Not Completed 1
Arm/Group Title Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Hide Arm/Group Description

Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.

gemcitabine hydrochloride: Given IV

cisplatin: Given IV

therapeutic conventional surgery: Undergo radical cystectomy

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
The tumor in patients was graded by TNM staging where T refers to the stage of primary tumor, n refers to the regional lymph nodes, M refers to distant metastasis. T0 - no evidence of primary tumor; N0- no regional lymph nodes; M0-no distant metastasis
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
69
(51 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
10
  32.3%
Male
21
  67.7%
Baseline clinical stage  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
T2N0M0
11
  35.5%
T3N0M0
15
  48.4%
T4aN0Mo/TxN1M0
5
  16.1%
1.Primary Outcome
Title Pathological Complete Response Rate Following Chemotherapy Before Surgery
Hide Description Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Hide Arm/Group Description:

Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.

gemcitabine hydrochloride: Given IV

cisplatin: Given IV

therapeutic conventional surgery: Undergo radical cystectomy

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(16 to 48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Hide Arm/Group Description

Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.

gemcitabine hydrochloride: Given IV

cisplatin: Given IV

therapeutic conventional surgery: Undergo radical cystectomy

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Affected / at Risk (%)
Total   16/31 (51.61%) 
Blood and lymphatic system disorders   
Acute Renal Insufficiency  1/31 (3.23%) 
cerebral Infarction  1/31 (3.23%) 
Cardiac disorders   
Chest pain  2/31 (6.45%) 
Coronary Artey Disease  1/31 (3.23%) 
Myocardial Infarction  1/31 (3.23%) 
Atrial Fibrillation  1/31 (3.23%) 
Gastrointestinal disorders   
Constipation  1/31 (3.23%) 
Nausea  1/31 (3.23%) 
vomiting  2/31 (6.45%) 
Ileus  1/31 (3.23%) 
General disorders   
Fever  3/31 (9.68%) 
Infections and infestations   
infected lymphocele  1/31 (3.23%) 
bacteremia  1/31 (3.23%) 
Metabolism and nutrition disorders   
Dehydration  1/31 (3.23%) 
hyperkalemia  2/31 (6.45%) 
hypernatremia  1/31 (3.23%) 
hyperglycemia  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders   
Gout  1/31 (3.23%) 
Renal and urinary disorders   
Acute Kidney Injury  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
dyspnea  1/31 (3.23%) 
pneumonia  1/31 (3.23%) 
hemoptysis  1/31 (3.23%) 
Vascular disorders   
Deep Vein Thrombosis  2/31 (6.45%) 
hypotension  1/31 (3.23%) 
Pulmonary embolism  1/31 (3.23%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Affected / at Risk (%)
Total   31/31 (100.00%) 
Blood and lymphatic system disorders   
Anemia  29/31 (93.55%) 
Cardiac disorders   
Atrial Fibrilation  1/31 (3.23%) 
Chest pain  2/31 (6.45%) 
Myocardial Infarction  1/31 (3.23%) 
Sinus Brachycardia  1/31 (3.23%) 
Sinus Trachycardia  4/31 (12.90%) 
Cardiac Faliure  1/31 (3.23%) 
Acute coronary syndrome  1/31 (3.23%) 
Ear and labyrinth disorders   
Hearing Impaired  1/31 (3.23%) 
Eye disorders   
Blurred Vision  1/31 (3.23%) 
Tinnitus  6/31 (19.35%) 
Glaucoma  1/31 (3.23%) 
Gastrointestinal disorders   
Constipation  14/31 (45.16%) 
Diarrhea  6/31 (19.35%) 
Dysphagia  1/31 (3.23%) 
GERD  2/31 (6.45%) 
Ileus  4/31 (12.90%) 
Mucositis  4/31 (12.90%) 
Nausea  24/31 (77.42%) 
vomiting  5/31 (16.13%) 
Flatulence  1/31 (3.23%) 
General disorders   
chills  5/31 (16.13%) 
Edema  6/31 (19.35%) 
fatigue  30/31 (96.77%) 
fever  5/31 (16.13%) 
flu-like symptoms  2/31 (6.45%) 
infusion related reaction  2/31 (6.45%) 
Injection site reaction  3/31 (9.68%) 
extravasation  1/31 (3.23%) 
Infusion site extravasation  2/31 (6.45%) 
Infections and infestations   
Sepsis  1/31 (3.23%) 
Urinary tract infection  4/31 (12.90%) 
Skin Infection  1/31 (3.23%) 
Phlebitis  2/31 (6.45%) 
intra-abdominal infection  1/31 (3.23%) 
Investigations   
AST/SGOT  3/31 (9.68%) 
ALT/SGPT  4/31 (12.90%) 
Alkaline Phosphatase increased  15/31 (48.39%) 
blood bilirubin increased  1/31 (3.23%) 
creatinine increased  15/31 (48.39%) 
White blood cells decreased  4/31 (12.90%) 
ANC decreased  4/31 (12.90%) 
Platelet count decreased  9/31 (29.03%) 
lymphocyte count decreased  13/31 (41.94%) 
cardiac troponin increased  3/31 (9.68%) 
Weight loss  2/31 (6.45%) 
Dehydration  2/31 (6.45%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  11/31 (35.48%) 
Hypocalcemia  12/31 (38.71%) 
Hyperkalemia  12/31 (38.71%) 
Hypokalemia  14/31 (45.16%) 
Hypernatremia  8/31 (25.81%) 
Hyponatremia  10/31 (32.26%) 
Hypophosphatemia  3/31 (9.68%) 
Hyperglycemia  24/31 (77.42%) 
Hypoglycemia  1/31 (3.23%) 
Hypomagnesium  16/31 (51.61%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  5/31 (16.13%) 
Generalized muscle weakness  3/31 (9.68%) 
Pain in extremity  3/31 (9.68%) 
Flank pain  3/31 (9.68%) 
Nervous system disorders   
Dizziness  5/31 (16.13%) 
Dysgeusia  8/31 (25.81%) 
Headache  3/31 (9.68%) 
Peripheral sensory neuropathy  5/31 (16.13%) 
Psychiatric disorders   
Anxiety  12/31 (38.71%) 
Depression  1/31 (3.23%) 
Insomnia  3/31 (9.68%) 
Restlessness  1/31 (3.23%) 
Renal and urinary disorders   
Hematuria  3/31 (9.68%) 
Proteinuria  3/31 (9.68%) 
Urinary frequency  10/31 (32.26%) 
Acute kidney injury  2/31 (6.45%) 
urinary retention  1/31 (3.23%) 
Reproductive system and breast disorders   
pelvic pain  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1/31 (3.23%) 
Cough  2/31 (6.45%) 
Dyspnea  3/31 (9.68%) 
Epistaxis  1/31 (3.23%) 
Hiccups  2/31 (6.45%) 
Skin and subcutaneous tissue disorders   
Alopecia  6/31 (19.35%) 
Rash  1/31 (3.23%) 
Vascular disorders   
Hypertension  9/31 (29.03%) 
Hypotension  4/31 (12.90%) 
Thromboembolic event  3/31 (9.68%) 
lymphocele  1/31 (3.23%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth Plimack, MD
Organization: Fox Chase Cancer Center
Phone: 215-728-3889
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01611662     History of Changes
Other Study ID Numbers: ERP-GU-052
NCI-2012-00906 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB#12-015 ( Other Identifier: Fox Chase Cancer Center )
ERP-GU-052 ( Other Identifier: Fox Chase Cancer Center )
First Submitted: May 30, 2012
First Posted: June 5, 2012
Results First Submitted: December 27, 2016
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017