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A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

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Trial Information

A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John Seigne, MB

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068250

NCT ID:

NCT00006376

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • 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
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128