Trial Outcomes & Findings for S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium (NCT NCT00045630)
NCT ID: NCT00045630
Last Updated: 2013-05-27
Results Overview
Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )
Results posted on
2013-05-27
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
Eligible
|
75
|
|
Overall Study
Eligible and Began Protocol Therapy
|
74
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Refusal unrelated to adverse event
|
1
|
|
Overall Study
Progression/relapse
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Ineligible
|
2
|
Baseline Characteristics
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
Baseline characteristics by cohort
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
n=74 Participants
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Performance Status
0
|
50 participants
n=5 Participants
|
|
Age Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Performance Status
1
|
16 participants
n=5 Participants
|
|
Performance Status
Missing
|
8 participants
n=5 Participants
|
|
Clinical T Stage
T2
|
52 participants
n=5 Participants
|
|
Clinical T Stage
T3
|
17 participants
n=5 Participants
|
|
Clinical T Stage
T4a
|
5 participants
n=5 Participants
|
|
Prior Intravesical Therapy
Yes
|
11 participants
n=5 Participants
|
|
Prior Intravesical Therapy
No
|
59 participants
n=5 Participants
|
|
Prior Intravesical Therapy
Missing
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )Population: All eligible patients who started treatment were included in the analysis
Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
Outcome measures
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
n=74 Participants
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
|
46 percentage of participants
Interval 34.0 to 58.0
|
SECONDARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started treatment were included in the analysis
Overall survival is defined from the date of registration to date of death from any cause
Outcome measures
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
n=74 Participants
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Overall Survival (OS)
|
59 percentage of participants
Interval 45.0 to 72.0
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgeryPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
n=74 Participants
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Bilirubin increase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac ischemia/infarction
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Abnormal troponin I (cTnI)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Allergic reaction
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anemia
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Creatinine increase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea without colostomy
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Duodenal ulcer
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue/malaise/lethargy
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
GI-other
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemolysis
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Incontinence
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with 3-4 neutropenia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection, unk ANC
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukopenia
|
22 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Melena/ GI bleeding
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutropenia/granulocytopenia
|
41 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
SGPT (ALT) increase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombocytopenia
|
13 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ureteral obstruction
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Urinary tr infect w/ neutrop
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Urinary tr infect w/o neutrop
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vomiting
|
1 Participants
|
Adverse Events
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
n=74 participants at risk
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Gastrointestinal disorders
GI-other
|
1.4%
1/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
1.4%
1/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
Other adverse events
| Measure |
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
n=74 participants at risk
Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.2%
49/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Eye disorders
Blurred vision
|
6.8%
5/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
10.8%
8/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
28.4%
21/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
24.3%
18/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Gastrointestinal disorders
Nausea
|
41.9%
31/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
10.8%
8/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
9/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
General disorders
Edema
|
9.5%
7/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
General disorders
Fatigue/malaise/lethargy
|
82.4%
61/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
General disorders
Fever without neutropenia
|
10.8%
8/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
General disorders
Pain-other
|
18.9%
14/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
General disorders
Rigors/chills
|
12.2%
9/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Immune system disorders
Allergic reaction
|
8.1%
6/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
8.1%
6/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Infections and infestations
Infection, unk ANC
|
5.4%
4/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Infections and infestations
Urinary tr infect w/o neutrop
|
8.1%
6/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
Creatinine increase
|
9.5%
7/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
Leukopenia
|
64.9%
48/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
Lymphopenia
|
8.1%
6/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
Neutropenia/granulocytopenia
|
73.0%
54/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
SGOT (AST) increase
|
14.9%
11/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
SGPT (ALT) increase
|
20.3%
15/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
Thrombocytopenia
|
55.4%
41/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Investigations
Weight loss
|
10.8%
8/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Metabolism and nutrition disorders
Anorexia
|
24.3%
18/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
4/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.3%
15/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.8%
5/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.8%
5/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
7/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.8%
5/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
8/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Nervous system disorders
Dizziness/light headedness
|
6.8%
5/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Nervous system disorders
Headache
|
8.1%
6/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Nervous system disorders
Sensory neuropathy
|
9.5%
7/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Psychiatric disorders
Insomnia
|
5.4%
4/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Renal and urinary disorders
Dysuria
|
5.4%
4/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Renal and urinary disorders
Hematuria
|
5.4%
4/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
14.9%
11/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.1%
6/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.6%
36/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
5/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.2%
9/74 • Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place