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Home > "R" Clinical Trials Conditions > R115777 in Treating Patients With Advanced Bladder Cancer  R115777 in Treating Patients With Advanced Bladder Cancer
R115777 in Treating Patients With Advanced Bladder Cancer
For Condition: stage 2 bladder cancer,regional transitional cell cancer of the renal pelvis and ureter,stage 3 bladder cancer,stage 4 bladder cancer,transitional cell carcinoma of the bladder,recurrent transitional cell cancer of the renal pelvis and ureter,metastatic transitional cell cancer of the renal pelvis and ureter,recurrent bladder cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have advanced bladder cancer.
Details: OBJECTIVES: I. Determine the efficacy of R115777 in terms of objective response in patients with advanced transitional cell cancer of the urothelial tract. II. Determine the safety of this treatment regimen in these patients. III. Determine the time to disease progression in these patients with this treatment regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral R115777 every 12 hours for 21 days in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for at least 2 courses. Patients are followed every 3 months for up to 5 years. PROJECTED ACCRUAL: A total of 18-32 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 urothelial tract not curable by surgery or radiotherapy; Bladder, renal pelvis, or ureter; Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease; Poorly differentiated transitional cell carcinoma or predominant transitional cell carcinoma with foci of squamous differentiation or rare foci of adenocarcinoma allowed; No adenocarcinoma, small cell carcinoma, sarcoma, or squamous cell carcinoma - Bidimensionally measurable disease; No disease confined to the bladder only; No soft tissue disease irradiated within the past 2 months - No known active CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent myeloid colony stimulating factors - Chemotherapy: At least 12 months since prior adjuvant or neoadjuvant chemotherapy and recovered - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered - Surgery: At least 4 weeks since prior surgery and recovered - Other: No prior systemic therapy (including investigational agents) for metastatic bladder cancer; At least 4 weeks since prior intravesical therapy and recovered; At least 30 days since prior participation in other investigational drug trial; No concurrent intravesical therapy; No other concurrent therapy for cancer --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: SGOT no greater than 2 times upper limit of normal (ULN); Bilirubin normal - Renal: Creatinine no greater than 2 times ULN - Other: No unresolved, active bacterial infection requiring antibiotics; 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; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnSeigne, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068250; NCI-G00-1861,MCC-12162,MCC-IRB-5623,JRF-R115777-INT-10
Study Start Date: March 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006376
Other Recurrent Transitional Cell Cancer Of The Renal Pelvis And Ureter Studies:
1. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
2. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
3. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
4. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
5. Eflornithine in Treating Patients With Bladder Cancer
Related Studies:
Other recurrent transitional cell cancer of the renal pelvis and ureter Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
R115777 in Treating Patients With Advanced Bladder Cancer
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