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Home > "T" Clinical Trials Conditions > Trastuzumab in Treating Patients With Previously Treated, Locally Advanced or Metastatic Kidney Cancer  Trastuzumab in Treating Patients With Previously Treated, Locally Advanced or Metastatic Kidney Cancer
Trastuzumab in Treating Patients With Previously Treated, Locally Advanced or Metastatic Kidney Cancer
For Condition: 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
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced or metastatic kidney cancer.
Details: OBJECTIVES: I. Determine the efficacy of trastuzumab (Herceptin) in patients with previously treated, locally advanced or metastatic transitional cell carcinoma of the urothelium. II. Determine the safety of this drug in this patient population. III. Determine overall survival in this patient population. PROTOCOL OUTLINE: Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of the first week. Patients then receive trastuzumab (Herceptin) IV over 30 minutes weekly. Treatment may continue for more than 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed transitional cell carcinoma of the urothelium; No pure adenocarcinomas, pure squamous cell carcinomas, small cell carcinoma, or only small foci of transitional cell carcinoma (less than 10% of tumor specimen); Locally advanced (T4b) or metastatic (N2 or N3 or M1) HER2 expression (3+) as determined by immunochemistry - Must not be candidate for potentially curative surgery or radiotherapy - Bidimensionally measurable disease that has not been previously irradiated; No bone scan abnormalities alone; No bladder mass alone that is not measurable on imaging studies; Must have received at least 1 prior chemotherapy regimen for advanced or metastatic disease OR Developed recurrent disease less than 1 year after neoadjuvant or adjuvant chemotherapy for advanced disease - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior trastuzumab - Chemotherapy: See Disease Characteristics; At least 30 days since prior chemotherapy; If prior doxorubicin, cumulative dose must be no greater than 300 mg/m2 - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; Prior radiotherapy allowed provided treated area is not only site of measurable disease; At least 14 days since prior radiotherapy - Surgery: See Disease Characteristics; Prior surgery allowed provided treated area is not only site of measurable disease; At least 14 days since prior surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Greater than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST no greater than 2 times ULN - Renal: Creatinine clearance at least 30 mL/min - Cardiovascular: Ejection fraction at least normal level on echocardiogram or MUGA scan; No history of congestive heart failure; No active cardiac ischemia - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardSchilsky, Study Chair, Cancer and Leukemia Group B
Additional Information:
Study ID Numbers: CDR0000067476; CLB-90101,NCI-T99-0108,UCSF-99535
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004856
Other Metastatic Transitional Cell Cancer Of The Renal Pelvis And Ureter Studies:
1. SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
2. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
3. Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
4. R115777 in Treating Patients With Advanced Bladder Cancer
5. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
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Trastuzumab in Treating Patients With Previously Treated, Locally Advanced or Metastatic Kidney Cancer
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