Overview

R115777 in Treating Patients With Advanced Bladder Cancer

Status:
Completed

Trial end date:
2005-05-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborator:

National Cancer Institute (NCI)

Treatments:

Tipifarnib

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

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

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