Trial Outcomes & Findings for Gemzar, Cisp, Sunitinib Urothelial Ca (NCT NCT00821327)
NCT ID: NCT00821327
Last Updated: 2016-10-25
Results Overview
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
2 years
Results posted on
2016-10-25
Participant Flow
Participant milestones
| Measure |
Study Arm: Advanced/Metastatic UC
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Study Arm: Advanced/Metastatic UC
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Patient Request
|
1
|
|
Overall Study
Investigator Request
|
2
|
|
Overall Study
Sponsor Request
|
1
|
|
Overall Study
Disease Progression
|
13
|
|
Overall Study
Other/Unknown
|
5
|
Baseline Characteristics
Gemzar, Cisp, Sunitinib Urothelial Ca
Baseline characteristics by cohort
| Measure |
Study Arm: Advanced/Metastatic UC
n=36 Participants
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All eligible patients who meet the protocol-specified efficacy analyses requirements and who have received at least 1 dose of study drug.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Study Arm: Advanced/Metastatic UC
n=33 Participants
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.
|
48.5 Percentage of participants
Interval 30.8 to 66.5
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: ITT population
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
Study Arm: Advanced/Metastatic UC
n=36 Participants
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Progression-free Survival
|
8.0 Month
Interval 7.0 to 14.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: ITT population
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Outcome measures
| Measure |
Study Arm: Advanced/Metastatic UC
n=36 Participants
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Ovarall Survival (OS)
|
13.8 months
Interval 10.1 to 22.9
|
Adverse Events
Study Arm: Advanced/Metastatic UC
Serious events: 7 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Arm: Advanced/Metastatic UC
n=33 participants at risk
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
BLOOD PRESSURE INCREASED
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Infections and infestations
CELLULITIS
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
HEMOGLOBIN DECREASED
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY THORACIC
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Infections and infestations
PANCREATITIS
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.0%
1/33 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
Other adverse events
| Measure |
Study Arm: Advanced/Metastatic UC
n=33 participants at risk
Gemcitabine, Cisplatin, Sunitinib
Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.1%
2/33 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
9.1%
3/33 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
ALT INCREASED
|
6.1%
2/33 • Number of events 5 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
ANEMIA
|
66.7%
22/33 • Number of events 78 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
ANOREXIA
|
24.2%
8/33 • Number of events 8 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
AST INCREASED
|
6.1%
2/33 • Number of events 6 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
BLEEDING NOSE
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
CONSTIPATION
|
27.3%
9/33 • Number of events 10 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
CREATININE CLEARANCE DECREASED
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
CREATININE SERUM INCREASED
|
9.1%
3/33 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
DEHYDRATION
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
DIARRHEA
|
18.2%
6/33 • Number of events 10 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Nervous system disorders
DIZZINESS
|
6.1%
2/33 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
EDEMA
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
FATIGUE
|
54.5%
18/33 • Number of events 34 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX
|
27.3%
9/33 • Number of events 9 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
HAND-FOOT SYNDROME
|
9.1%
3/33 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Nervous system disorders
HEADACHE
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Renal and urinary disorders
HEMATURIA
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
HICCUP
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Cardiac disorders
HYPERTENSION
|
15.2%
5/33 • Number of events 8 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
9.1%
3/33 • Number of events 5 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
INSOMNIA
|
9.1%
3/33 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
LEUCOPENIA
|
30.3%
10/33 • Number of events 40 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Infections and infestations
MUCOSAL SORES
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
NAUSEA
|
48.5%
16/33 • Number of events 22 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Nervous system disorders
NEUROPATHY
|
6.1%
2/33 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
90.9%
30/33 • Number of events 113 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
PAIN
|
12.1%
4/33 • Number of events 5 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.1%
4/33 • Number of events 6 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
21.2%
7/33 • Number of events 8 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
72.7%
24/33 • Number of events 88 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
VOMITING
|
21.2%
7/33 • Number of events 9 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
WEIGHT LOSS
|
12.1%
4/33 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
Additional Information
Dr. Matthew D. Galsky
US Oncology Research, McKesson Specialty Health
Phone: 212-659-5412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place