Trial Outcomes & Findings for Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC (NCT NCT00859339)
NCT ID: NCT00859339
Last Updated: 2016-04-14
Results Overview
number of participants with a pCR
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
18 months
Results posted on
2016-04-14
Participant Flow
Participant milestones
| Measure |
CGS + Radical Cystectomy
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
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|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
Baseline characteristics by cohort
| Measure |
CGS + Radical Cystectomy
n=9 Participants
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
|
|---|---|
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Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 8 participants were evaluable for pCR
number of participants with a pCR
Outcome measures
| Measure |
CGS + Radical Cystectomy
n=8 Participants
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
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|---|---|
|
Pathological Complete Response (pCR) Rate.
|
2 particpants with pCR
|
SECONDARY outcome
Timeframe: 18 monthsEvaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC
Outcome measures
| Measure |
CGS + Radical Cystectomy
n=9 Participants
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
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|---|---|
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Safety Profile
Perioperative bleeding
|
4 participants
|
|
Safety Profile
neutropenia
|
2 participants
|
|
Safety Profile
neutropenic fever
|
1 participants
|
|
Safety Profile
thrombocytopenia
|
1 participants
|
|
Safety Profile
anemia
|
1 participants
|
|
Safety Profile
nausea/emesis
|
3 participants
|
|
Safety Profile
syncope
|
2 participants
|
|
Safety Profile
myocardial infarction
|
1 participants
|
|
Safety Profile
fatigue
|
1 participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)
To determine the objective response rate for patients with measurable disease according to RECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)
To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.
Outcome measures
Outcome data not reported
Adverse Events
CGS + Radical Cystectomy
Serious events: 7 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CGS + Radical Cystectomy
n=9 participants at risk
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
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|---|---|
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Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
HEMORRHAGE, GU / BLADDER
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / KIDNEY
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Infections and infestations
INFECTION - OTHER
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / WOUND
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
NAUSEA
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Renal and urinary disorders
OBSTRUCTION, GU / BLADDER
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
ULCER, GI / ESOPHAGUS
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
VOMITING
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
Other adverse events
| Measure |
CGS + Radical Cystectomy
n=9 participants at risk
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
|
|---|---|
|
Gastrointestinal disorders
ANOREXIA
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Renal and urinary disorders
BLADDER SPASMS
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.2%
2/9 • Number of events 4 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Investigations
CREATININE
|
44.4%
4/9 • Number of events 6 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
DEHYDRATION
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
DIARRHEA
|
33.3%
3/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
22.2%
2/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
33.3%
3/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
66.7%
6/9 • Number of events 10 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
11.1%
1/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
11.1%
1/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
55.6%
5/9 • Number of events 13 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
HEMORRHAGE, GU / BLADDER
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Injury, poisoning and procedural complications
HEMORRHAGE/BLEEDING ASSOCIATED WITH SURGERY, INTRA-OPERATIVE OR POSTOPERATIVE
|
44.4%
4/9 • Number of events 4 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Cardiac disorders
HYPERTENSION
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Cardiac disorders
HYPOTENSION
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
General disorders
INSOMNIA
|
33.3%
3/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
33.3%
3/9 • Number of events 8 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
11.1%
1/9 • Number of events 5 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
3/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
55.6%
5/9 • Number of events 11 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Renal and urinary disorders
OBSTRUCTION, GU / BLADDER
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Renal and urinary disorders
PAIN / BLADDER
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
General disorders
PAIN / BUTTOCK
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Cardiac disorders
PAIN / CARDIAC/HEART
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
General disorders
PAIN / HEAD/HEADACHE
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
22.2%
2/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
General disorders
PAIN - OTHER
|
11.1%
1/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Blood and lymphatic system disorders
PLATELETS
|
33.3%
3/9 • Number of events 6 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
22.2%
2/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
|
11.1%
1/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
11.1%
1/9 • Number of events 2 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
Gastrointestinal disorders
VOMITING
|
22.2%
2/9 • Number of events 3 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
|
General disorders
WEIGHT LOSS
|
11.1%
1/9 • Number of events 1 • From on-study to off-study, a maximum of four cycles plus time for recovery and radical cystectomy, a maximum of six months.
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place