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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
sunitinib malate
immunohistochemistry staining method
laboratory biomarker analysis
pharmacological study
quality-of-life assessment
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Del MarRecruiting
  • Hospital de la Santa Cruz i Sant PauRecruiting
  • Hospital Universitario San CarlosRecruiting
  • Hospital Universitario 12 de OctubreRecruiting

Outcomes

Primary Outcome Measures

Time to disease progression
Safety

Secondary Outcome Measures

Progression-free survival
Overall response rate
Overall survival
Time to treatment failure
Pharmacodynamic profile
Quality of life

Full Information

First Posted
May 5, 2010
Last Updated
August 6, 2013
Sponsor
Hospital del Mar
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1. Study Identification

Unique Protocol Identification Number
NCT01118039
Brief Title
Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer
Official Title
A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital del Mar

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary To determine the time to disease progression (defined as the time from diagnosis of metastatic urothelial carcinoma until first confirmed progression of the disease) in patients with locally recurrent, locally advanced, unresectable, or metastatic urothelial cancer treated with sunitinib malate and ineligible for cisplatin-based chemotherapy. To determine the safety of this drug in these patients. Secondary To determine the progression-free survival of patients treated with this drug. To determine the overall response rate in patients treated with this drug. To determine the overall survival of patients treated with this drug. To determine the time to treatment failure in patients treated with this drug. To determine the pharmacodynamic profile of this drug in pre- and post-treatment serum and tumor tissue (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis [H/E]) at week 6, and if possible, at time of progression. To determine the quality of life of patients treated with this drug using the QLQ-C30 version 3 questionnaire. OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients complete quality-of-life questionnaire (EORTC QLQ-C30) before, during, and at the end of study treatment. Serum and tumor tissue samples are collected at baseline and after study treatment for pharmacodynamic studies. Samples are analyzed for markers (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis [H/E]) via immunohistochemistry. After completion of study treatment, patients are followed for 28 days and then every 2 months for up to 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Time to disease progression
Title
Safety
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Overall response rate
Title
Overall survival
Title
Time to treatment failure
Title
Pharmacodynamic profile
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim Bellmunt, MD, PhD
Organizational Affiliation
Hospital del Mar
Facility Information:
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
34-39-3248-3861
Email
XVillanueva@imas.imim.es
Facility Name
Hospital de la Santa Cruz i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
34-93-553-7118
Email
jmaroto@santpau.cat
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
34-91-330-3000, Ext. 7935
Email
jgonzalezl.hcsc@salud.madrid.org
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
34-91-469-2313
Email
cdanicas@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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