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Study Summary
No. DM00-039:.......Bladder......Arlene Siefker-Radtke......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:
DM00-039
Study Title:PHASE II TRIAL OF IFOSFAMIDE & DOXORUBICIN ALTERNATING WITH VP-16 & CISPLATIN FOR SMALL CELL CARCINOMA OF THE UROTHELIUM
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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:2Return
Visit:
Q 6 Weeks
Treatment
Agents:
Isophosphamide
Doxorubicin
Etoposide
Cisplatin
Home Care:Any Chemotherapy After 1st Cycle
Treatment Loc:inpatient
Estimated
Length of Stay
in Houston:
Q 21 Days
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:04/27/2000
IRB Review and Approval Date:03/01/2000
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:30
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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:Pts with detectable disease limited to bladder, no clinical or radiographically evaluable disease needed, For metastatic disease, at least 1 site must be measurable.

No previous therapy for metastatic disease allowed. Relapsed pts, (neo)adjuvant therapy is OK. Prior intravessical therapy is ok.

Previously treated pts myst fit guidelines: prior cummulative dose of doxorubicin</=200mg/m2; no more than 15% of bone marrow in previous areas of irradiation; no delays of >1 wk in delivering any previous chemo regimen.

Zubrod</=2(3 if of recent onset & due to cancer);normal WBC,ANC>/=1800;platelets>150,000;transaminase</=2xULN.

Conjugataed bilirubin</=1.0mg/dL(or total bilirubin<2mg/dL); creatinine>/=45mL/min; CL(cr)=[(140-age) x wt(kg)]/{72 x Creat(mg/dL)] For females, x 0.85).

Pts with uncontrolled CNS metastases are not eligible.

Pts with an abnormal EKG or a history of cardiac disease, or prior exposure to doxorubicin must have a determination of LV function.

Women of child-bearing potential must have a neg preg. test before starting therapy.

.Histologic proof of urothelial small cell carcinoma, for mixed histology, small cell must be the clinically relevant component. Dr. Siefker-Radtke will serve as the final arbiter regarding discussion on mixed histology.


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