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Study Summary
No. ID99-393:.......Bladder......Arlene Siefker-Radtke......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:		ID99-393
Study Title:A randomized phase II selection trial of 4 chemotherapy regimens in urothelial cancer
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Physician New Patient Referral
Name:Arlene Siefker-RadtkePatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:BladderSupported By:none
Phase of Study:Phase IIReturn
Visit:		Every 6 weeks
Treatment
Agents:		Isophosphamide
Mesna
Paclitaxel
Cisplatin
G-CSF
Doxorubicin
LY 188011		Home Care:Any course after 1st
Treatment Loc:inpatient
Estimated
Length of Stay
in Houston:		Variable
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:04/10/2000
IRB Review and Approval Date:02/02/2000
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:120
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:Histologic demonstration of metastatic or locally unresectable transitional cell carcinoma of the urothelium, variant histology ok if<50%.

Measurable or evaluable disease:3 dimensional mass or pelvic sidewall fixation, liver & lung lesions at least 1 cm, node-only disease pts with lesions >/= 1.5cm, bone pt with measurable lytic defect present or elevated serum marker>4xULN.

Life expectancy >/= 9 months (based on co-morbidity) & at least 8 wks based on natural history of their cancer.

Zubrod performance status </= 2.

No clinical history of ht disease, normal ECG or EF measured by ECHO, MUGA or ventriculography of at least 50%.

Transaminase & conjugated bilirubin less than 2 x ULN.

Serum creatinine</=2mg/dL or creatinine clearance of at least 50mL/min.

ANC>/=1,500; platelets>/=150.

Histologic demonstration of metastatic or locally unresectable transitional cell carcinoma of the urothelium

Measurable or evaluable disease:3 dimensional mass or pelvic sidewall fixation, liver & lung lesions at least 1 cm, node-only disease pts with lesions > /= 1.5cm, bone pt with measurable lytic defect present or elevated serum marker > 4xULN

Life expectancy > /= 9 months (based on co-morbidity) & at least 8 wks based on natural history of their cancer

Zubrod performance status < /= 2

No clinical history of ht disease & normal ECG or EF measured by ECHO, MUGA or ventriculography of at least 50%

Transaminase & conjugated bilirubin < 2 x ULN

Serum creatinine < /=2mg/dL or creatinine clearance of at least 50mL/min

ANC > /=1,500; platelets > /=150
Exclusion Criteria:Variant history > 50%.

Active secondary malignancy.

Pregnant.

Lactating.

Previous (Neo) adjuvant rx.

Uncontrolled CNS mets.

Pts must be at least 6 wks out from pelvic irradiation, & must not have had more than 10% of the bone marrow irradiated.

Variant histology > 50%

Active secondary malignancy.

Pregnant

Lactating

Previous (Neo) adjuvant rx

Uncontrolled CNS mets
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Links
Registration Number:
Other Links:
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Results

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