S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00022633
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 65
• Locations: 92
• Arm: 1
• Duration (Months): 120
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer	Drug: gemcitabine hydrochloride; Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES:

• Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study.

• Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients.

• Assess the toxicity and tolerability of this regimen in these elderly patients.

• Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients.

• Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years.

OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs under 60).

Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)
• Study Start Date: Jul 1, 2001
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gemcitabine, paclitaxel	Drug: gemcitabine hydrochloride; Drug: paclitaxel; Other Names: Taxol

Outcome Measures

Primary Outcome Measures

1. Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols [66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)]

   Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.

Secondary Outcome Measures

1. Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response) [every week for the first 4 weeks and then every 3 weeks for up to 19 weeks]

   Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

2. Progression-free Survival in Patients Aged 70 Years and Older [0-5 years]

   Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.

3. Overall Survival (OS) in Patients Aged 70 Years and Older [0-5 years]

   Measured from date of registration to date of death due to any cause.

4. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.]

   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.

5. Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate [at study entry (prior to administration of any treatment)]

   Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

6. Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms [at study entry (prior to administration of any treatment)]

   Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

7. Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required [at study entry (prior to administration of any treatment)]

   Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed urothelial cancer

• Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder, renal pelvis, ureter, or urethra)

• Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes) disease OR

• Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible for further radiotherapy or surgery

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• 70 and over OR

• Under 60

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,200/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2 times ULN

Renal:

• Creatinine no greater than ULN

Other:

• HIV negative

• No other concurrent life-threatening medical disorder that would preclude study participation

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago

• No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 28 days since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics

• At least 28 days since prior surgery and recovered

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
4	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia	United States	31603
5	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
6	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
7	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
8	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
9	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
10	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
11	Southwest Medical Center	Liberal	Kansas	United States	67901
12	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
13	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
14	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
15	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
16	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
17	Stormont-Vail Cancer Center	Topeka	Kansas	United States	66604
18	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
19	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
20	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67203
21	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
22	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
23	CCOP - Wichita	Wichita	Kansas	United States	67214
24	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
25	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
26	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
27	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
28	Bay Regional Medical Center	Bay City	Michigan	United States	48708
29	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
30	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
31	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
32	Spectrum Health Hospital - Butterworth Campus	Grand Rapids	Michigan	United States	49503
33	Metropolitan Hospital	Grand Rapids	Michigan	United States	49506
34	Holland Community Hospital	Holland	Michigan	United States	49423
35	Hackley Hospital	Muskegon	Michigan	United States	49443
36	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
37	Munson Medical Center	Traverse City	Michigan	United States	49684
38	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
39	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
40	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
41	St. Vincent Healthcare	Billings	Montana	United States	59101
42	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
43	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
44	St. James Community Hospital	Butte	Montana	United States	59701
45	Big Sky Oncology	Great Falls	Montana	United States	59405
46	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
47	St. Peter's Hospital	Helena	Montana	United States	59601
48	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
49	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
50	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
51	Community Medical Center	Missoula	Montana	United States	59801
52	Clinic of Dr. Judy L. Schmidt	Missoula	Montana	United States	59804
53	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
54	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
55	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska	United States	68848-1990
56	Finger Lakes Hematology and Oncology	Clifton Springs	New York	United States	14432
57	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
58	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
59	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
60	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
61	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
62	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
63	Wilson Medical Center	Wilson	North Carolina	United States	27893-3428
64	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
65	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
66	Community Oncology Group at Cleveland Clinic Cancer Center	Independence	Ohio	United States	44131
67	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
68	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
69	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
70	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
71	Medical City Dallas Hospital	Dallas	Texas	United States	75230
72	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
73	Wilford Hall Medical Center	Lackland AFB	Texas	United States	78236
74	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
75	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
76	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
77	University Hospital - San Antonio	San Antonio	Texas	United States	78229
78	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
79	Danville Regional Medical Center	Danville	Virginia	United States	24541
80	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
81	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
82	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington	United States	98273
83	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
84	Harborview Medical Center	Seattle	Washington	United States	98104
85	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
86	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
87	Polyclinic First Hill	Seattle	Washington	United States	98122
88	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
89	North Puget Oncology at United General Hospital	Sedro-Wooley	Washington	United States	98284
90	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
91	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
92	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Derek Raghavan, MD, PhD, FRACP, FACP, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00022633
• Other Study ID Numbers: CDR0000068837; S0028; U10CA032102
• First Posted: Jan 27, 2003
• Last Update Posted: Aug 11, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Southwest Oncology Group: recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; squamous cell carcinoma of the bladder; adenocarcinoma of the bladder; recurrent urethral cancer; anterior urethral cancer; posterior urethral cancer; urethral cancer associated with invasive bladder cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms; Gemcitabine; Paclitaxel

Study Results

Participant Flow

Recruitment Details	The purpose of the subset of patients who aged 60 years or younger was to serve as a younger reference group for the pharmacokinetic parameter estimation. Therefore, this younger cohort is not included in analyses of adverse event, efficacy, and feasibility assessment of patient-reported outcome measures.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)	Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Period Title: Overall Study
STARTED	55	10
Eligible	51	10
COMPLETED	23	5
NOT COMPLETED	32	5

Baseline Characteristics

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)	Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)	Total
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)	Total of all reporting groups
Overall Participants	51	10	61
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	76.1	53.8	74.6
Sex: Female, Male (Count of Participants)
Female	14 27.5%	4 40%	18 29.5%
Male	37 72.5%	6 60%	43 70.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 5.9%	1 10%	4 6.6%
Not Hispanic or Latino	47 92.2%	9 90%	56 91.8%
Unknown or Not Reported	1 2%	0 0%	1 1.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2%	0 0%	1 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	1 10%	1 1.6%
Black or African American	4 7.8%	1 10%	5 8.2%
White	46 90.2%	7 70%	53 86.9%
More than one race	0 0%	1 10%	1 1.6%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Secondary Outcome

Title	Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)
Description	Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
Time Frame	every week for the first 4 weeks and then every 3 weeks for up to 19 weeks

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	51
Number (95% Confidence Interval) [percentage of participants]	22 43.1%

2. Secondary Outcome

Title	Progression-free Survival in Patients Aged 70 Years and Older
Description	Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.
Time Frame	0-5 years

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	51
Median (95% Confidence Interval) [months]	6

3. Secondary Outcome

Title	Overall Survival (OS) in Patients Aged 70 Years and Older
Description	Measured from date of registration to date of death due to any cause.
Time Frame	0-5 years

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	51
Median (95% Confidence Interval) [months]	11

4. Secondary Outcome

Title	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
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 weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded

Arm/Group Title	Paclitaxel + Gemcitabine
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	51
Abdominal pain/cramping	2 3.9%
Acidosis	1 2%
Allergic reaction	1 2%
Anemia	6 11.8%
Anorexia	3 5.9%
Bone pain	1 2%
Cardiac ischemia/infarction	1 2%
Chest pain,not cardio or pleur	1 2%
Confusion	1 2%
Constipation/bowel obstruction	2 3.9%
Creatinine increase	1 2%
Dehydration	1 2%
Diarrhea without colostomy	1 2%
Dizziness/light headedness	1 2%
Dyspepsia/heartburn	1 2%
Dyspnea	6 11.8%
Edema	1 2%
Fatigue/malaise/lethargy	8 15.7%
Febrile neutropenia	1 2%
Gastric ulcer	1 2%
Hyperglycemia	3 5.9%
Hyperkalemia	2 3.9%
Hypotension	2 3.9%
Infection w/o 3-4 neutropenia	1 2%
Infection with 3-4 neutropenia	3 5.9%
Infection, unk ANC	1 2%
Leukopenia	6 11.8%
Muscle weakness (not neuro)	1 2%
Myalgia/arthralgia, NOS	1 2%
Nausea	3 5.9%
Neuropathic pain	1 2%
Neutropenia/granulocytopenia	26 51%
PRBC transfusion	10 19.6%
Pain-other	3 5.9%
Pleural effusions	1 2%
Pneumonitis/infiltrates	1 2%
Renal failure	1 2%
Respiratory infect w/ neutrop	1 2%
SGOT (AST) increase	1 2%
Sensory neuropathy	3 5.9%
Supraventricular arrhythmia	1 2%
Thrombocytopenia	2 3.9%
Thrombosis/embolism	2 3.9%
Urinary tr infect w/ neutrop	2 3.9%
Urinary tr infect w/o neutrop	2 3.9%
Ventricular arrhythmia	2 3.9%
Vomiting	1 2%
Weakness (motor neuropathy)	2 3.9%

5. Primary Outcome

Title	Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
Description	Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.
Time Frame	66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)

Outcome Measure Data

Analysis Population Description

A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	55
Number [participants]	55 107.8%

6. Secondary Outcome

Title	Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate
Description	Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Time Frame	at study entry (prior to administration of any treatment)

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	51
Medical Conditions Questionnaire	98 192.2%
Instrumental Activities of Daily Living Form	98 192.2%
Feelings Questionnaire	98 192.2%

7. Secondary Outcome

Title	Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
Description	Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Time Frame	at study entry (prior to administration of any treatment)

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	50
Medical Conditions Questionnaire	5
Instrumental Activities of Daily Living Form	3
Feelings Questionnaire	2

8. Secondary Outcome

Title	Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required
Description	Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Time Frame	at study entry (prior to administration of any treatment)

Outcome Measure Data

Analysis Population Description

Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.

Arm/Group Title	Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
Measure Participants	50
Medical Conditions Questionnaire	28 54.9%
Instrumental Activities of Daily Living Form	42 82.4%
Feelings Questionnaire	34 66.7%

Adverse Events

Time Frame	Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.
Adverse Event Reporting Description	Elderly Cohort (Age >= 70 years)
Arm/Group Title	Paclitaxel + Gemcitabine
Arm/Group Description	Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
All Cause Mortality
	Paclitaxel + Gemcitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paclitaxel + Gemcitabine
	Affected / at Risk (%)	# Events
Total	5/51 (9.8%)
Cardiac disorders
Cardiovascular-other	1/51 (2%)
Supraventricular arrhythmia	1/51 (2%)
Gastrointestinal disorders
Ileus	1/51 (2%)
General disorders
Flu-like symptoms-other	1/51 (2%)
Reportable adverse event, NOS	2/51 (3.9%)
Infections and infestations
Respiratory infect w/ neutrop	1/51 (2%)
Metabolism and nutrition disorders
Acidosis	1/51 (2%)
Dehydration	1/51 (2%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/51 (2%)
Other (Not Including Serious) Adverse Events
	Paclitaxel + Gemcitabine
	Affected / at Risk (%)	# Events
Total	50/51 (98%)
Blood and lymphatic system disorders
Anemia	29/51 (56.9%)
PRBC transfusion	10/51 (19.6%)
Eye disorders
Blurred vision	4/51 (7.8%)
Gastrointestinal disorders
Abdominal pain/cramping	6/51 (11.8%)
Constipation/bowel obstruction	16/51 (31.4%)
Diarrhea without colostomy	12/51 (23.5%)
Esophagitis/dysphagia	3/51 (5.9%)
Nausea	25/51 (49%)
Stomatitis/pharyngitis	4/51 (7.8%)
Vomiting	9/51 (17.6%)
General disorders
Edema	14/51 (27.5%)
Fatigue/malaise/lethargy	42/51 (82.4%)
Fever without neutropenia	8/51 (15.7%)
Pain-other	8/51 (15.7%)
Rigors/chills	6/51 (11.8%)
Sweating	4/51 (7.8%)
Immune system disorders
Allergic reaction	3/51 (5.9%)
Infections and infestations
Infection with 3-4 neutropenia	3/51 (5.9%)
Urinary tr infect w/o neutrop	4/51 (7.8%)
Investigations
Alkaline phosphatase increase	8/51 (15.7%)
Creatinine increase	7/51 (13.7%)
Leukopenia	12/51 (23.5%)
Neutropenia/granulocytopenia	36/51 (70.6%)
SGOT (AST) increase	11/51 (21.6%)
SGPT (ALT) increase	4/51 (7.8%)
Thrombocytopenia	20/51 (39.2%)
Weight loss	6/51 (11.8%)
Metabolism and nutrition disorders
Anorexia	23/51 (45.1%)
Hyperglycemia	7/51 (13.7%)
Hyperkalemia	3/51 (5.9%)
Hypoalbuminemia	4/51 (7.8%)
Hypocalcemia	3/51 (5.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	9/51 (17.6%)
Bone pain	3/51 (5.9%)
Myalgia	20/51 (39.2%)
Nervous system disorders
Dizziness/light headedness	8/51 (15.7%)
Headache	5/51 (9.8%)
Neuropathic pain	4/51 (7.8%)
Sensory neuropathy	21/51 (41.2%)
Taste disturbance	4/51 (7.8%)
Weakness (motor neuropathy)	5/51 (9.8%)
Psychiatric disorders
Confusion	4/51 (7.8%)
Insomnia	12/51 (23.5%)
Renal and urinary disorders
Urinary frequency/urgency	3/51 (5.9%)
Respiratory, thoracic and mediastinal disorders
Cough	9/51 (17.6%)
Dyspnea	17/51 (33.3%)
Hiccoughs	3/51 (5.9%)
Skin and subcutaneous tissue disorders
Alopecia	27/51 (52.9%)
Rash/desquamation	4/51 (7.8%)
Vascular disorders
Hypotension	3/51 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

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.