Trial Outcomes & Findings for Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer (NCT NCT01611662)
NCT ID: NCT01611662
Last Updated: 2019-07-29
Results Overview
Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2019-07-29
Participant Flow
Participant milestones
| Measure |
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
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 Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
n=31 Participants
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
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Baseline clinical stage
T2N0M0
|
11 Participants
n=5 Participants
|
|
Baseline clinical stage
T3N0M0
|
15 Participants
n=5 Participants
|
|
Baseline clinical stage
T4aN0Mo/TxN1M0
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
Outcome measures
| Measure |
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
n=31 Participants
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
|
|---|---|
|
Pathological Complete Response Rate Following Chemotherapy Before Surgery
|
32 percentage of participants
Interval 16.0 to 48.0
|
Adverse Events
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
Serious events: 16 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
n=31 participants at risk
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
|
|---|---|
|
Cardiac disorders
Chest pain
|
6.5%
2/31
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.5%
2/31
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.2%
1/31
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31
|
|
Blood and lymphatic system disorders
Acute Renal Insufficiency
|
3.2%
1/31
|
|
Cardiac disorders
Coronary Artey Disease
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.2%
1/31
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
1/31
|
|
Vascular disorders
hypotension
|
3.2%
1/31
|
|
Vascular disorders
Pulmonary embolism
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.2%
1/31
|
|
Infections and infestations
infected lymphocele
|
3.2%
1/31
|
|
General disorders
Fever
|
9.7%
3/31
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31
|
|
Infections and infestations
bacteremia
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
hyperkalemia
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
hypernatremia
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
hyperglycemia
|
3.2%
1/31
|
|
Gastrointestinal disorders
vomiting
|
6.5%
2/31
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Gout
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
3.2%
1/31
|
|
Blood and lymphatic system disorders
cerebral Infarction
|
3.2%
1/31
|
Other adverse events
| Measure |
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
n=31 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
93.5%
29/31
|
|
Cardiac disorders
Atrial Fibrilation
|
3.2%
1/31
|
|
Cardiac disorders
Chest pain
|
6.5%
2/31
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
1/31
|
|
Cardiac disorders
Sinus Brachycardia
|
3.2%
1/31
|
|
Cardiac disorders
Sinus Trachycardia
|
12.9%
4/31
|
|
Cardiac disorders
Cardiac Faliure
|
3.2%
1/31
|
|
Cardiac disorders
Acute coronary syndrome
|
3.2%
1/31
|
|
Ear and labyrinth disorders
Hearing Impaired
|
3.2%
1/31
|
|
Eye disorders
Blurred Vision
|
3.2%
1/31
|
|
Eye disorders
Tinnitus
|
19.4%
6/31
|
|
Gastrointestinal disorders
Constipation
|
45.2%
14/31
|
|
Gastrointestinal disorders
Diarrhea
|
19.4%
6/31
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31
|
|
Gastrointestinal disorders
GERD
|
6.5%
2/31
|
|
Gastrointestinal disorders
Ileus
|
12.9%
4/31
|
|
Gastrointestinal disorders
Mucositis
|
12.9%
4/31
|
|
Gastrointestinal disorders
Nausea
|
77.4%
24/31
|
|
Gastrointestinal disorders
vomiting
|
16.1%
5/31
|
|
General disorders
chills
|
16.1%
5/31
|
|
General disorders
Edema
|
19.4%
6/31
|
|
General disorders
fatigue
|
96.8%
30/31
|
|
General disorders
fever
|
16.1%
5/31
|
|
General disorders
flu-like symptoms
|
6.5%
2/31
|
|
General disorders
infusion related reaction
|
6.5%
2/31
|
|
Reproductive system and breast disorders
pelvic pain
|
3.2%
1/31
|
|
Infections and infestations
Sepsis
|
3.2%
1/31
|
|
Infections and infestations
Urinary tract infection
|
12.9%
4/31
|
|
Investigations
AST/SGOT
|
9.7%
3/31
|
|
General disorders
Injection site reaction
|
9.7%
3/31
|
|
Investigations
ALT/SGPT
|
12.9%
4/31
|
|
Investigations
Alkaline Phosphatase increased
|
48.4%
15/31
|
|
Investigations
blood bilirubin increased
|
3.2%
1/31
|
|
Investigations
creatinine increased
|
48.4%
15/31
|
|
Investigations
White blood cells decreased
|
12.9%
4/31
|
|
Investigations
ANC decreased
|
12.9%
4/31
|
|
Investigations
Platelet count decreased
|
29.0%
9/31
|
|
Investigations
lymphocyte count decreased
|
41.9%
13/31
|
|
Investigations
cardiac troponin increased
|
9.7%
3/31
|
|
Investigations
Weight loss
|
6.5%
2/31
|
|
Investigations
Dehydration
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
35.5%
11/31
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
38.7%
12/31
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
38.7%
12/31
|
|
Metabolism and nutrition disorders
Hypokalemia
|
45.2%
14/31
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.8%
8/31
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.3%
10/31
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
77.4%
24/31
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Hypomagnesium
|
51.6%
16/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
5/31
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.7%
3/31
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31
|
|
Nervous system disorders
Dysgeusia
|
25.8%
8/31
|
|
Nervous system disorders
Headache
|
9.7%
3/31
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.1%
5/31
|
|
Psychiatric disorders
Anxiety
|
38.7%
12/31
|
|
Psychiatric disorders
Depression
|
3.2%
1/31
|
|
Psychiatric disorders
Insomnia
|
9.7%
3/31
|
|
Psychiatric disorders
Restlessness
|
3.2%
1/31
|
|
Renal and urinary disorders
Hematuria
|
9.7%
3/31
|
|
Renal and urinary disorders
Proteinuria
|
9.7%
3/31
|
|
Renal and urinary disorders
Urinary frequency
|
32.3%
10/31
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.4%
6/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31
|
|
Infections and infestations
Skin Infection
|
3.2%
1/31
|
|
Vascular disorders
Hypertension
|
29.0%
9/31
|
|
Vascular disorders
Hypotension
|
12.9%
4/31
|
|
Vascular disorders
Thromboembolic event
|
9.7%
3/31
|
|
General disorders
extravasation
|
3.2%
1/31
|
|
Vascular disorders
lymphocele
|
3.2%
1/31
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31
|
|
Infections and infestations
Phlebitis
|
6.5%
2/31
|
|
Infections and infestations
intra-abdominal infection
|
3.2%
1/31
|
|
Renal and urinary disorders
urinary retention
|
3.2%
1/31
|
|
Eye disorders
Glaucoma
|
3.2%
1/31
|
|
General disorders
Infusion site extravasation
|
6.5%
2/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place