Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract

NCT00112671 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-03095PHL-0367062N01CM62203
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well sorafenib works in treating patients with advanced or metastatic cancer of the urinary tract. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Paricipants With Tumour Response Defined as Partial or Complete Response Per the RECIST 1.0 Criteria

  Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

  Up to 5 years

Secondary Outcomes (4)

• Number of Participants With Stable Disease for More Than 3 Months

  From the start of the treatment until the criteria for progression are met, up to 5 years

• Time to Progression

  Up to 5 years

• Progression-free Survival

  From start of treatment to progression or death, assessed up to 1 year

• Frequency of Common Grade 3 Adverse Events

  Up to 5 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

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

Drug: sorafenib tosylate; Other: laboratory biomarker analysis

Interventions

sorafenib tosylate DRUG

Given orally 400mg orally twice daily

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Treatment (sorafenib tosylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (sorafenib tosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 therapy
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Srikala Sridhar
• Organization: Princess Margaret Phase II Consortium

srikala.sridhar@uhn.ca

416-946-4501

Study Officials

• Srikala Sridhar

  Princess Margaret Hospital Phase 2 Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: April 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 27, 2018
• Results First Posted: September 3, 2015

Record last verified: 2018-07

Locations

CA (1)