Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer

NCT01118039 | Unknown Phase 2

• 4 other identifiers: HDM-SU-011248CDR0000671673EUDRACT-2005-005115-16PFIZER-HDM-SU-011248
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Sunitinib malate 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. PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to see how well it works in treating patients with locally recurrent, locally advanced, unresectable, or metastatic urinary tract cancer.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Keywords

localized transitional cell cancer of the renal pelvis and ureter; metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; transitional cell carcinoma of the bladder; distal urethral cancer; proximal urethral cancer; recurrent urethral cancer; recurrent bladder cancer; stage IV bladder cancer; stage III bladder cancer; urethral cancer associated with invasive bladder cancer; stage III urethral cancer; stage IV urethral cancer

Outcome Measures

Primary Outcomes (2)

• Time to disease progression

• Safety

Secondary Outcomes (6)

• Progression-free survival

• Overall response rate

• Overall survival

• Time to treatment failure

• Pharmacodynamic profile

Interventions

sunitinib malate DRUG

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

quality-of-life assessment PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed transitional cell carcinoma of the urinary tract meeting ≥ 1 of the following criteria: * Unresectable, locally recurrent disease * Locally recurrent disease must not be amenable to resection or radiotherapy with curative intent * Locally advanced or metastatic disease * No prior chemotherapy for advanced disease * Ineligible (unfit) for cisplatin-based chemotherapy due to creatinine clearance \< 60 mL/min but \> 30 mL/min * Measurable or nonmeasurable disease according to RECIST criteria * Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy PATIENT CHARACTERISTICS: * See Disease Characteristics * ECOG performance status 0-1 * Life expectancy \> 12 weeks * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 9.0 g/dL * Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Serum creatinine ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy) * Serum albumin ≥ 3.0 g/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during study therapy * No diagnosis of a second malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix * None of the following within the past 12 months: * Myocardial infarction * Severe/unstable angina * Coronary/peripheral artery bypass graft * Congestive heart failure * Cerebrovascular accident, including transient ischemic attack * Pulmonary embolus * No ongoing cardiac dysrhythmias (NCI CTCAE grade ≥ 2), atrial fibrillation of any grade, or QTc interval \> 450 msec (males) or \> 470 msec (females) * No hypertension that cannot be controlled by medications (\> 150/100 mm Hg despite optimal medical therapy) * No known HIV infection * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which would make the patient inappropriate for entry into this study PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all acute toxic effects of prior therapy or surgical procedures to grade ≤ 1 (except alopecia) * At least 3 weeks since prior major surgery, radiotherapy, or systemic therapy (except palliative radiotherapy to non-target metastatic lesions) * Not enrolled in a dialysis program or anticipating a need for dialysis * No prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract * No prior treatment on another sunitinib malate clinical trial * No prior tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors * No prior high-dose chemotherapy requiring hematopoietic stem cell rescue * No prior radiotherapy to \> 25% of the bone marrow * No concurrent treatment on another clinical trial * No concurrent treatment with therapeutic doses of acenocoumarol

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (4)

Hospital Del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Sunitinib; Immunohistochemistry

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; Urethral Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Joaquim Bellmunt, MD, PhD

  Hospital del Mar

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: July 1, 2006
• Primary Completion: December 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2012-09

Locations

ES (4)