Afatinib in Advanced Refractory Urothelial Cancer

Status Recruiting

Clinical Trial Summary

This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the 3-month progression free survival (PFS) rate in metastatic urothelial cancer patients receiving afatinib (afatinib dimaleate) who have progressed despite prior platinum-based chemotherapy. SECONDARY OBJECTIVES: I. To determine the overall response rate (complete response [CR] + partial response [PR]), median progression free survival, and overall survival for the same treated population. II. To determine whether tumor epidermal growth factor receptor (EGFR) and/or HER2 overexpression influences 3-month PFS in patients treated with afatinib. OUTLINE: Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02122172
Study type	Interventional
Source	University of Chicago
Contact
Status	Recruiting
Phase	Phase 2
Start date	October 30, 2013
Completion date	June 12, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03229278` - Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma	Phase 1
Completed	`NCT01938573` - Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer	Phase 1/Phase 2
Completed	`NCT01846520` - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers	N/A
Terminated	`NCT00112905` - Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium	Phase 2
Terminated	`NCT00072137` - Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy	Phase 1
Completed	`NCT00072150` - Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma	Phase 2
Completed	`NCT00028756` - Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium	Phase 3
Completed	`NCT00407485` - VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium	Phase 2
Terminated	`NCT00003452` - Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder	Phase 2
Completed	`NCT00003167` - Gene Therapy in Treating Patients With Advanced Bladder Cancer	Phase 1
Completed	`NCT00005831` - Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer	Phase 2
Completed	`NCT00021099` - Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer	Phase 2
Terminated	`NCT01382706` - Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder	Phase 2
Active, not recruiting	`NCT04267575` - Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites	N/A
Terminated	`NCT01954173` - Adjuvant Radiation for High Risk Bladder Cancer	N/A
Terminated	`NCT00004856` - Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium	Phase 2
Active, not recruiting	`NCT04670445` - Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer	N/A
Terminated	`NCT01282333` - Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer	Phase 1
Completed	`NCT01828736` - Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma	Phase 2
Terminated	`NCT02316548` - Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer	Phase 2