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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01118039
First received: May 5, 2010
Last updated: August 6, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: sunitinib malate
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Pharmacodynamic profile [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: July 2006
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118039

Locations
Spain
Hospital de la Santa Cruz i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Contact Person    34-93-553-7118    jmaroto@santpau.cat   
Hospital Del Mar Recruiting
Barcelona, Spain, 08003
Contact: Contact Person    34-39-3248-3861    XVillanueva@imas.imim.es   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Contact Person    34-91-469-2313    cdanicas@hotmail.com   
Hospital Universitario San Carlos Recruiting
Madrid, Spain, 28040
Contact: Contact Person    34-91-330-3000, Ext. 7935    jgonzalezl.hcsc@salud.madrid.org   
Sponsors and Collaborators
Hospital del Mar
Investigators
Investigator: Joaquim Bellmunt, MD, PhD Hospital del Mar
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01118039     History of Changes
Other Study ID Numbers: HDM-SU-011248, CDR0000671673, EUDRACT-2005-005115-16, PFIZER-HDM-SU-011248
Study First Received: May 5, 2010
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urinary Bladder Neoplasms
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ureteral Diseases
Urethral Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014