Pazopanib in Treating Patients With Metastatic Urothelial Cancer

NCT00471536 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00203CDR0000543460MAYO-MC0553MC05537661N01CM62205
• Study Type: interventional
• Target: 19
• Locations: 3 countries
• Sites: 9

Brief Summary

This phase II trial is studying the side effects and how well pazopanib works in treating patients with metastatic urothelial cancer. Pazopanib 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.

Conditions

Distal Urethral Cancer; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Urethral Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder; Urethral Cancer Associated With Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])

  Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria: A Complete Response (CR) requires the disappearance of all target lesions. A Partial Response (PR) requires \>=30% decrease in the sum of the longest diameter of target lesions from baseline measurement. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.

  Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.

Secondary Outcomes (5)

• Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

  Every 4 weeks during treatment (maximum duration was 44 weeks)

• Confirmed Tumor Response (CR and PR)

  Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year

• Duration of Response

  From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year

• Time to Disease Progression

  Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration

• Survival Time

  Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: pazopanib hydrochloride

Interventions

pazopanib hydrochloride DRUG

800 mg Given orally

Also known as: GW786034B, Votrient

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed transitional cell cancer of the urothelium or bladder
• Metastatic disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• No known brain metastases
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Platelet count ≥ 100,000/mm\^3
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• PT/INR/PTT ≤ 1.2 times ULN
• No proteinuria \> 1+ on two consecutive dipsticks measured ≥ 1 week apart
• Not pregnant or nursing

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Metro-Minnesota CCOP

Saint Louis Park, Minnesota, 55416, United States

Location

Cox Medical Center

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, Hong Kong, OX1 3UJ, China

Location

Gangnam Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

pazopanib

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

Results Point of Contact

• Title: Ulka Vaishampayan, M.D.
• Organization: Karmanos Cancer Institute at Wayne State University

vaishamu@karmanos.org

Study Officials

• Ulka Vaishampayan

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2013
• Last Updated: May 30, 2014
• Results First Posted: March 21, 2013

Record last verified: 2013-12

Locations

CN (1); KR (1); US (7)