Trial Outcomes & Findings for Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin (NCT NCT02030574)
NCT ID: NCT02030574
Last Updated: 2016-08-24
Results Overview
Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 \[Eur J Cancer. 2009;45:228-247.\].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
at approximately 6 months
Results posted on
2016-08-24
Participant Flow
Participant milestones
| Measure |
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
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|---|---|
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Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin
Baseline characteristics by cohort
| Measure |
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
n=2 Participants
1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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2 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at approximately 6 monthsResponse will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 \[Eur J Cancer. 2009;45:228-247.\].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie
Outcome measures
| Measure |
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
n=2 Participants
1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
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|---|---|
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Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.
|
2 participants
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SECONDARY outcome
Timeframe: Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)Toxicities assessed while patients are on treatments
Outcome measures
| Measure |
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
n=2 Participants
1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
|
|---|---|
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Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer
|
2 participants
|
Adverse Events
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
n=2 participants at risk
1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
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|---|---|
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Blood and lymphatic system disorders
thromboembolic event and pain right arm
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
Other adverse events
| Measure |
Gemcitabine and Fractionated Cisplatin (Combination Treatment)
n=2 participants at risk
1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.
GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
|
|---|---|
|
Blood and lymphatic system disorders
phlebitis
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Gastrointestinal disorders
urinary frequency
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Platelet Count
|
100.0%
2/2 • Number of events 2 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Sodium
|
100.0%
2/2 • Number of events 2 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
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Blood and lymphatic system disorders
Hemaglobin/anemia
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Absolute Neutrofil Count
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
epistaxis
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
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General disorders
fatigue
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
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Musculoskeletal and connective tissue disorders
joint knee swelling
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
facial flushing
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Magnesium
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
General disorders
pain
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Gastrointestinal disorders
urinary incontinence
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
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General disorders
abdomnial pain
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Gastrointestinal disorders
Acute Kidney Infection
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Gastrointestinal disorders
hydronephrosis (urostomy obstruction)
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Investigations
lymphocele
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
General disorders
cough
|
100.0%
2/2 • Number of events 2 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Cardiac disorders
dyspnea/Shorness Of Breath
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Investigations
Urinary Track Infection
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Sepsis
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
pulmonary embolism
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Albumin
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Blood and lymphatic system disorders
Potassium
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Gastrointestinal disorders
persistent urine leak (moderate per site not a gradable event)(pt 1)
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
General disorders
abd fluid collection (moderate per site not a gradable event)(pt 1)
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
|
Gastrointestinal disorders
decreased urine drainage ( mild per site not a gradeable event)(pt 1)
|
50.0%
1/2 • Number of events 1 • Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place