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Study Summary
No. ID01-317:.......Gastrointestinal; Bladder......Arlene Siefker-Radtke......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:
ID01-317
Study Title:PHASE 2 TRIAL OF NEOADJUVANT, MULTI-AGENT CHEMOTHERAPY FOR LOCALLY ADVANCED 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:Gastrointestinal
Bladder
Supported By:Charlene Curlee Fund
Phase of Study:Phase IIReturn
Visit:
Must be in Houston for at least first 12 days. Treatment away from MDACC possible after that.
Treatment
Agents:
Isophosphamide
Mesna
Doxorubicin
LY 188011
G-CSF
Cisplatin
Home Care:Any, after first 12 days.
Treatment Loc:both inpatient and outpatient
Estimated
Length of Stay
in Houston:
Variable; defined by tolerance.
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:07/24/2001
IRB Review and Approval Date:07/18/2001
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:65
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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 proof of urothelial cancer; all subtypes except small cell carcinoma as predominant invasive component.

Primary tumors arising in the bladder are elig if: lymphovascular involvement on TUR specimen with>/=cT1 invasion, 3-D mass on EUA (cT3b), or direct invasion of prostatic stroma or the vaginal wall (cT4a)

Pt with more than focal areas of micropapillary Hx are elig, even if they do not meet anatomic criteria for locally advanced disease.

Primary tumors arising in the ureter or renal pelvis are elig if Grade 3 cancers or radiographic abnormality lg enough to recognize as abnormal mass by CT/MRI.

No evidence of disease beyond confines of pelvis by either CT or MRI of the abdomen & pelvis & chest x-ray.Bone scan or no bone pain indicating no evidence of met disease & alk phos<150% ULN or normal bone fraction of alk phos.

Abnormal EKG or history of cardiac disease requires determination of LV function & EF of at least 50% to participate.

Women of childbearing potential must have neg preg test.

Second malig pts OK if expected outcome from the second Cx will not interfere with delivery of therapy or assessment of response in the cystectomy specimen, & expected survival for any prior malignancy is reliably >4 yrs.

Dr. Czerniak will be consulted in equivocal cases of mixed histology, and Dr. Siefker-Radtke will serve as arbiter if questions of eligibility based on histology arise.

Zubrod</=2(3 if recent onsent&due to Cx&not comorbidity);normal WBC,ANC>/=1800,platelets>150,000(Supranormal values judged benign/inconsequential etiology ok);transaminase</=3xULN, conjugated bili</=1.5mg/dL or (total</=2.5mg/dL);CrC>/=45mL/min.


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