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Trial record 19 of 32 for:    "Urethra Cancer" | "Antimetabolites, Antineoplastic"

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium

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ClinicalTrials.gov Identifier: NCT00045630
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 27, 2013
Last Update Posted : May 27, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Interventions Drug: carboplatin
Drug: gemcitabine
Drug: paclitaxel
Procedure: surgery
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 77
Eligible 75
Eligible and Began Protocol Therapy 74
Completed 71
Not Completed 6
Reason Not Completed
Adverse Event             1
Refusal unrelated to adverse event             1
Progression/relapse             1
Death             1
Ineligible             2
Arm/Group Title Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Hide Arm/Group Description 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 Number of Baseline Participants 74
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 74 participants
69
(49 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
18
  24.3%
Male
56
  75.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Hispanic or Latino
3
   4.1%
Not Hispanic or Latino
55
  74.3%
Unknown or Not Reported
16
  21.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
American Indian or Alaska Native
1
   1.4%
Asian
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   2.7%
White
70
  94.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 74 participants
0 50
1 16
Missing 8
[1]
Measure Description: Patients will be graded according to the Zubrod performance status scale. 0: Fully active, able to carry all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. 2: Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Clinical T Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 74 participants
T2 52
T3 17
T4a 5
[1]
Measure Description: Primary Tumor (T): TX Primary tumor cannot be assessed, T0 No evidence of primary tumor, Ta Non-invasive papillary carcinoma, Tis Carcinoma in situ: "flat tumor", T1 Tumor invades subepithelial connective tissue, T2 Tumor invades muscle, pT2a Tumor invades superficial muscle (inner half), pT2b Tumor invades deep muscle (outer half), T3 Tumor invades perivesical tissue, pT3a Microscopically, pT3b Macroscopically (extravesical mass), T4 Tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall, T4a Tumor invades prostate, uterus, vagina.
Prior Intravesical Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 74 participants
Yes 11
No 59
Missing 4
1.Primary Outcome
Title Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
Hide Description 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.
Time Frame up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Hide Arm/Group Description:
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 Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46
(34 to 58)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined from the date of registration to date of death from any cause
Time Frame 0-2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Hide Arm/Group Description:
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 Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59
(45 to 72)
3.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hide Description 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.
Time Frame Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Hide Arm/Group Description:
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 Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: Participants
Abnormal troponin I (cTnI) 1
Allergic reaction 2
Anemia 5
Bilirubin increase 1
Cardiac ischemia/infarction 1
Creatinine increase 1
Diarrhea without colostomy 2
Duodenal ulcer 1
Dyspnea 1
Fatigue/malaise/lethargy 3
Febrile neutropenia 2
GI-other 1
Hemolysis 1
Incontinence 1
Infection with 3-4 neutropenia 2
Infection, unk ANC 2
Leukopenia 22
Lymphopenia 1
Melena/ GI bleeding 1
Neutropenia/granulocytopenia 41
SGPT (ALT) increase 1
Thrombocytopenia 13
Ureteral obstruction 1
Urinary tr infect w/ neutrop 1
Urinary tr infect w/o neutrop 1
Vomiting 1
Time Frame Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Hide Arm/Group Description 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.
All-Cause Mortality
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Affected / at Risk (%)
Total   2/74 (2.70%) 
Gastrointestinal disorders   
GI-other  1  1/74 (1.35%) 
Infections and infestations   
Infection with 3-4 neutropenia  1  1/74 (1.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
Affected / at Risk (%)
Total   73/74 (98.65%) 
Blood and lymphatic system disorders   
Anemia  1  49/74 (66.22%) 
Eye disorders   
Blurred vision  1  5/74 (6.76%) 
Gastrointestinal disorders   
Abdominal pain/cramping  1  8/74 (10.81%) 
Constipation/bowel obstruction  1  21/74 (28.38%) 
Diarrhea without colostomy  1  18/74 (24.32%) 
Nausea  1  31/74 (41.89%) 
Stomatitis/pharyngitis  1  8/74 (10.81%) 
Vomiting  1  9/74 (12.16%) 
General disorders   
Edema  1  7/74 (9.46%) 
Fatigue/malaise/lethargy  1  61/74 (82.43%) 
Fever without neutropenia  1  8/74 (10.81%) 
Pain-other  1  14/74 (18.92%) 
Rigors/chills  1  9/74 (12.16%) 
Immune system disorders   
Allergic reaction  1  6/74 (8.11%) 
Infections and infestations   
Infection w/o 3-4 neutropenia  1  6/74 (8.11%) 
Infection, unk ANC  1  4/74 (5.41%) 
Urinary tr infect w/o neutrop  1  6/74 (8.11%) 
Investigations   
Creatinine increase  1  7/74 (9.46%) 
Leukopenia  1  48/74 (64.86%) 
Lymphopenia  1  6/74 (8.11%) 
Neutropenia/granulocytopenia  1  54/74 (72.97%) 
SGOT (AST) increase  1  11/74 (14.86%) 
SGPT (ALT) increase  1  15/74 (20.27%) 
Thrombocytopenia  1  41/74 (55.41%) 
Weight loss  1  8/74 (10.81%) 
Metabolism and nutrition disorders   
Anorexia  1  18/74 (24.32%) 
Dehydration  1  4/74 (5.41%) 
Hyperglycemia  1  15/74 (20.27%) 
Hypoalbuminemia  1  5/74 (6.76%) 
Hyponatremia  1  5/74 (6.76%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/74 (9.46%) 
Bone pain  1  5/74 (6.76%) 
Myalgia  1  8/74 (10.81%) 
Nervous system disorders   
Dizziness/light headedness  1  5/74 (6.76%) 
Headache  1  6/74 (8.11%) 
Sensory neuropathy  1  7/74 (9.46%) 
Psychiatric disorders   
Insomnia  1  4/74 (5.41%) 
Renal and urinary disorders   
Dysuria  1  4/74 (5.41%) 
Hematuria  1  4/74 (5.41%) 
Urinary frequency/urgency  1  11/74 (14.86%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  6/74 (8.11%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  36/74 (48.65%) 
Pruritus  1  5/74 (6.76%) 
Rash/desquamation  1  9/74 (12.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Publications of Results:
Lara PN, Goldman B, De Vere White R, et al.: A sequential treatment approach to muscle-invasive urothelial cancer: A phase II Southwest Oncology Group trial (S0219) of neoadjuvant paclitaxel, carboplatin, and gemcitabine (PCG). [Abstract] J Clin Oncol 26 (Suppl 15): A-5022, 2008.
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00045630     History of Changes
Obsolete Identifiers: NCT00191217
Other Study ID Numbers: CDR0000256921
S0219 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2002
First Posted: January 27, 2003
Results First Submitted: November 15, 2012
Results First Posted: May 27, 2013
Last Update Posted: May 27, 2013