NCT00022633 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2016-08-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)

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outcome · POSTED

Progression-free Survival in Patients Aged 70 Years and Older

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outcome · POSTED

Overall Survival (OS) in Patients Aged 70 Years and Older

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outcome · POSTED

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

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outcome · POSTED

Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols

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outcome · POSTED

Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate

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outcome · POSTED

Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms

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outcome · POSTED

Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 120 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: gemcitabine hydrochloride
Drug: paclitaxel
label
gemcitabine, paclitaxel
type
EXPERIMENTAL

interventions

arm Group Labels
gemcitabine, paclitaxel
name
gemcitabine hydrochloride
type
DRUG
arm Group Labels
gemcitabine, paclitaxel
name
paclitaxel
other Names
Taxol
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 65
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

secondary Outcomes

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.
measure
Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)
time Frame
every week for the first 4 weeks and then every 3 weeks for up to 19 weeks
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.
measure
Progression-free Survival in Patients Aged 70 Years and Older
time Frame
0-5 years
description
Measured from date of registration to date of death due to any cause.
measure
Overall Survival (OS) in Patients Aged 70 Years and Older
time Frame
0-5 years
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.
measure
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
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.
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.
measure
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate
time Frame
at study entry (prior to administration of any treatment)
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.
measure
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
time Frame
at study entry (prior to administration of any treatment)
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.
measure
Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required
time Frame
at study entry (prior to administration of any treatment)

Full 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.
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.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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query cond
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice