- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006376
R115777 in Treating Patients With Advanced Bladder Cancer
A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: John Seigne, MB, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III bladder cancer
- recurrent bladder cancer
- stage IV bladder cancer
- metastatic transitional cell cancer of the renal pelvis and ureter
- recurrent transitional cell cancer of the renal pelvis and ureter
- transitional cell carcinoma of the bladder
- regional transitional cell cancer of the renal pelvis and ureter
- stage II bladder cancer
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Ureteral Diseases
- Kidney Neoplasms
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Antineoplastic Agents
- Tipifarnib
Other Study ID Numbers
- CDR0000068250
- MCC-12162
- JRF-R115777-INT-10
- MCC-IRB-5623
- NCI-G00-1861
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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