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.

Condition	Treatment or Intervention	Phase
stage III bladder cancer stage II bladder cancer regional transitional cell cancer of the renal pelvis and ureter transitional cell carcinoma of the bladder recurrent bladder cancer stage IV bladder cancer recurrent transitional cell cancer of the renal pelvis and ureter metastatic transitional cell cancer of the renal pelvis and ureter	Drug: R115777	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States

Study chairs or principal investigators

John Seigne,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

Study ID Numbers:  CDR0000068250; MCC-12162; NCI-G00-1861; JRF-R115777-INT-10; MCC-IRB-5623
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006376
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08