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R115777 in Treating Patients With Advanced Bladder Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006376
  Purpose

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 Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: tipifarnib
Procedure: chemotherapy
Phase II

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

ChemIDplus related topics:   Tipifarnib   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2000

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006376

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

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     John Seigne, MB     H. Lee Moffitt Cancer Center and Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068250, MCC-12162, JRF-R115777-INT-10, MCC-IRB-5623, NCI-G00-1861
First Received:   October 4, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006376
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II bladder cancer  
stage III bladder cancer  
recurrent bladder cancer  
stage IV bladder cancer  
transitional cell carcinoma of the bladder
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

Study placed in the following topic categories:
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Renal cancer
Kidney cancer
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Kidney Diseases
Ureteral Neoplasms
Urinary tract neoplasm
Tipifarnib
Bladder neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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