Status:
TERMINATED
Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Bladder
Distal Urethral Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well sorafenib works in treating patients with progressive regional or metastatic cancer of the urothelium. Sorafenib may stop the growth of tumor cells by blocking...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the 4-month progression-free survival rate, response rate and toxicity of BAY 43-9006 in patients with progressing regional or metastatic transitional cell carcinom...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed transitional cell carcinoma or mixed histologies containing a component of transitional cell carcinoma of the urothelium (renal pelvis, ureter, bladder, urethra) with manifestations of progressing regional or metastatic cancer; or (2) Nontransitional cell histologies include patients with adenocarcinoma or squamous cell carcinomas representing greater than 90% of specimen; patients with small cell carcinoma, soft tissue sarcomas, or carcinosarcomas are excluded
- Measurable disease, as defined in the RECIST criteria; all sites of disease must be evaluated within 4 weeks prior to registration
- Patients must have progressed on one and only one prior systemic chemotherapy for metastatic disease; prior chemotherapy administered in the adjuvant or neoadjuvant setting is permitted (i.e. does not count as 1 prior regimen) provided that it was completed greater than 12 months prior to the start of the first chemotherapy regimen administered in the metastatic setting
- Patients must not have had prior systemic biologic response modifier therapy; patients must not have had chemotherapy, hormonal or biologic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have recovered from adverse events due to agents administered more than 4 weeks earlier
- Prior radiotherapy is allowed; patients must be \>= 2 weeks post-radiotherapy at time of registration; a previously irradiated lesion can only be used as a marker lesion if there is unequivocal evidence of progression demonstrated on serial imaging studies; patients must have recovered from all toxicities associated with prior radiotherapy
- Patients must be \>= 4 weeks post-major surgery at time of registration; patients must have recovered from all toxicities associated with prior surgery
- ECOG performance status of 0 or 1
- No history of severe cardiovascular disease (AHA Class III or IV), uncontrolled CHF, uncontrolled hypertension, or ventricular dysrhythmias
- Patients with previously resected and irradiated CNS metastases with evidence of stable disease are eligible
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for \>= 5 years; curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix must have been treated with curative intent; patients with clinically unsuspected organ confined prostate cancer found at the time of cystoprostatectomy are eligible
- Creatinine \< 1.5 mg/dL
- Granulocytes \>= 1500/mm\^3
- Platelets \>= 100,000/mm\^3
- AST =\< 2.5 x institutional upper limit of normal
- Bilirubin \< 1.5 mg/dl
- No active unresolved infection requiring parenteral antibiotics \< 7 days prior to study entry
- Patients must not have a swallowing dysfunction which would prevent the ingesting of pills
- Patients must not have any evidence of bleeding diathesis
- Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation (i.e. 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, and phenobarbital), rifampin, or St. John's Wort
- Women of childbearing potential must not be pregnant (as proven by a negative pregnancy test within 14 days prior to registration) or breast feeding because the effects of this treatment on the fetus and breast-fed infants is unknown
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00112905
Start Date
October 1 2005
End Date
March 1 2008
Last Update
May 30 2014
Active Locations (1)
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1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215