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A Phase II Study of BAY 43-9006 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter and Renal Pelvis)

Phase 2
18 Years
Not Enrolling
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter, Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder

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Trial Information

A Phase II Study of BAY 43-9006 in Advanced or Metastatic Urothelial Cancer (Transitional Cell Cancer of the Bladder, Ureter and Renal Pelvis)


I. To assess the efficacy (response rate and stable disease rate) of Bay 439006 given to
patients with advanced or metastatic urothelial cancer.

II. To assess the toxicity, time to progression and response duration of Bay 439006 given to
patients with advanced or metastatic urothelial cancer.

III. To measure Ras mutational status and EGFR/HER2 on archival specimens. To determine
baseline and post-treatment levels of pERK, pAKT, VEGFR2, CD31, Ki-67/MIB-1, and cleaved
caspase 3 and to explore the relationship between these correlative endpoints and clinical

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 3 weeks and then every 3
months thereafter.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed transitional cell cancer
of the bladder, renal pelvis or ureter

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral CT scan

- Patients must not have had any prior systemic therapy for advanced or metastatic
disease; prior adjuvant or neoadjuvant chemotherapy is permitted providing it was
completed at least 4 weeks prior to study entry; radiation therapy is permitted if
completed > 4 weeks prior to trial entry

- Life expectancy of greater than 3 months

- ECOG performance status 0 or 1 (Karnofsky >= 70%)

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

- Creatinine < 1.5 x ULN OR creatinine clearance >= 45 mL/min/1.73 m^2

- No serious medical conditions such as myocardial infarction within 6 months prior to
entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable
ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders,
serious infections, active peptic ulcer disease, or any other medical conditions that
might be aggravated by treatment

- Patients must have tumor lesions accessible for biopsy for correlative studies and
must be willing to undergo tumor biopsy once before and once during experimental
therapy; if there is a medical contraindication to biopsy, exception may be granted
upon discussion with the Principal Investigator/Chair

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Able to swallow and retain oral medication

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Prior systemic therapy for advanced or metastatic urothelial carcinoma

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents

- Patients receiving any other investigational agents, or concurrent anticancer

- Patients with only non-measurable disease, defined as all other lesions, including
small lesions (longest diameter < 20mm with conventional techniques or < 10 mm with
spiral CT scan) and truly non-measurable lesions, which include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound evaluation of neurologic and other adverse events

- Patients with a history of other active malignancy in the past 5 years (with the
exception of adequately treated cervical carcinoma in situ and non melanomatous skin
cancers) are excluded

- Uncontrolled intercurrent illness including, but no limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Patients must not have any evidence of a bleeding diathesis

- Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation
(ie. Low dose warfarin) of venous or arterial access devices is allowed provided that
the requirements for PT, INR or PTT are met

- Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs
(phenytoin, carbamazepine, or Phenobarbital), rifampin or St. John's Wort

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with BAY 43-9006

- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BAY 43-9006

- Patients with GI tract disease resulting in an inability to take oral medication,
malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures
affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity of BAY 43-9006 using objective tumor response rate defined as partial or complete response by the RECIST criteria

Outcome Description:

Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Srikala Sridhar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital Phase 2 Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Bladder Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage III Bladder Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urologic Neoplasms